21 CFR Part 876 — Gastroenterology-Urology Devices

PART 876—GASTROENTEROLOGY-UROLOGY DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted. Subpart A—General Provisions Editorial Note: Nomenclature changes to part 876 appear at 73 FR 35341, June 23, 2008. § 876.1 Scope. (a) This part sets forth the classification of gastroenterology-urology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, a gastroenterology-urology device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.. [52 FR 17737, May 11, 1987; 52 FR 22577, June 12, 1987, as amended at 69 FR 77623, Dec. 28, 2004; 78 FR 18233, Mar. 26, 2013] § 876.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. [52 FR 17737, May 11, 1987] § 876.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2316, Jan. 14, 2000] Subpart B—Diagnostic Devices § 876.1050 Endoscopic transhepatic venous access needle. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of the patient-contacting components of the device. (3) The patient-contacting components of the device must be demonstrated to be non-pyrogenic. (4) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be tested: (i) Needle crumple testing; (ii) Tensile testing; (iii) Dimensional verification for all components; and (iv) Simulated use testing. (6) Labeling must include the following: (i) Instructions for use, including specific instructions regarding device preparation; (ii) The recommended training for safe use of the device; and (iii) A shelf life for any sterile components. [86 FR 71145, Dec. 15, 2021] § 876.1075 Gastroenterology-urology biopsy instrument. (a) Identification. (b) Classification. (2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001] § 876.1080 Gastroenterology-urology accessories to a biopsy instrument. (a) Identification. (b) Classification. [84 FR 14869, Apr. 12, 2019] § 876.1300 Ingestible telemetric gastrointestinal capsule imaging system. (a) Identification. (b) Classification. [67 FR 3433, Jan. 24, 2002] § 876.1310 Magnetically maneuvered capsule endoscopy system. (a) Identification. (b) Classification. (1) Clinical performance testing with the device under anticipated conditions of use must evaluate visualization of the intended region and document the adverse event profile. (2) Non-clinical testing data must demonstrate the optical, mechanical, and functional integrity of the device under physically stressed conditions. The following performance characteristics must be tested, and detailed protocols must be provided for each test: (i) A bite test must be performed to ensure that the capsule can withstand extreme cases of biting; (ii) A pH resistance test must be performed to evaluate integrity of the capsule when exposed to a physiological relevant range of pH values; (iii) A battery life test must be performed to demonstrate that the capsule's operating time is not constrained by the battery capacity; (iv) A shelf life test must be performed to demonstrate that the device performs as intended at the proposed shelf life date; (v) Optical testing must be performed to evaluate fundamental image quality characteristics such as resolution, field of view, depth of field, geometric distortion, signal to noise ratio, dynamic range, and image intensity uniformity; (vi) A color performance test must be performed to compare the color differences between the input scene and output image; (vii) A photobiological safety analysis must be performed based on maximum (worst-case) light exposure to internal gastrointestinal mucosa, and covering ultraviolet, visible, and near-infrared ranges, as appropriate. A mitigation analysis must be provided; (viii) Performance testing must demonstrate that the viewing software clearly presents the current frame rate, which is either adjustable manually by the user or automatically by the device. Testing must demonstrate that the viewing software alerts the user when the video quality is reduced from nominal due to imaging data communication or computation problems; (ix) A data transmission test must be performed to verify the robustness of the data transmission between the capsule and the receiver. This test must include controlled signal attenuation for simulating a non-ideal environment; and (x) Magnetic field strength testing characterization must be performed to identify the distances from the magnet that are safe for patients and users with ferromagnetic implants, devices, or objects. (3) Software validation, verification, and hazard analysis must be provided. (4) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility testing must be performed. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Performance data must validate the reprocessing instructions for the reusable components of the device. (7) Performance data must demonstrate the sterility of any device components labeled sterile. (8) Human factors testing must demonstrate that the intended users can safely and correctly use the device, based solely on reading the instructions for use. (9) Clinician labeling must include: (i) Specific instructions and the clinical and technical expertise needed for the safe use of the device; (ii) A detailed summary of the clinical testing pertinent to use of the device, including information on effectiveness and device- and procedure-related complications; (iii) The patient preparation procedure; (iv) A detailed summary of the device technical parameters; (v) Magnetic field safe zones; (vi) A screening checklist to ensure that all patients and operating staff are screened from bringing ferromagnetic implants, devices, or objects near the external magnet; (vii) Reprocessing instructions for reusable components; (viii) Shelf life for single use components; and (ix) Use life for reusable components. (10) Patient labeling must include: (i) An explanation of the device and the mechanism of operation; (ii) The patient preparation procedure; (iii) A brief summary of the clinical study; and (iv) A summary of the device- and procedure-related complications pertinent to use of the device. [87 FR 26993, May 6, 2022] § 876.1330 Colon capsule endoscopy system. (a) Identification. (b) Classification. (1) The capsule must be demonstrated to be biocompatible. (2) Non-clinical testing data must demonstrate the mechanical and functional integrity of the device under physically stressed conditions. The following performance characteristics must be tested and detailed protocols must be provided for each test: (i) Bite test to ensure that the capsule can withstand extreme cases of biting. (ii) pH resistance test to evaluate integrity of the capsule when exposed to a range of pH values. (iii) Battery life test to demonstrate that the capsule's operating time is not constrained by the battery capacity. (iv) Shelf-life testing to demonstrate that the device performs as intended at the proposed shelf-life date. (v) Optical testing to evaluate fundamental image quality characteristics such as resolution, field of view, depth of field, distortion, signal-to-noise ratio, uniformity, and image artifacts. A test must be performed to evaluate the potential of scratches, caused by travelling through the gastrointestinal tract, on the transparent window of the capsule and their impact on the optical and color performance. (vi) An optical safety analysis must be performed based on maximum (worst-case) light exposure to internal gastrointestinal mucosa, and covering ultraviolet, visible, and near-infrared ranges, as appropriate. A mitigation analysis must be provided. (vii) A color performance test must be provided to compare the color differences between the input scene and output image. (viii) The video viewer must clearly present the temporal or spatial relationship between any two frames as a real-time lapse or a travel distance. The video viewer must alert the user when the specific video interval is captured at a frame rate lower than the nominal one due to communication errors. (ix) A performance test evaluating the latency caused by any adaptive algorithm such as adjustable frame rate must be provided. (x) If the capsule includes a localization module, a localization performance test must be performed to verify the accuracy and precision of locating the capsule position within the colon. (xi) A data transmission test must be performed to verify the robustness of the data transmission between the capsule and the recorder. Controlled signal attenuation should be included for simulating a non-ideal environment. (xii) Software validation, verification, and hazards analysis must be provided. (xiii) Electrical equipment safety, including thermal and mechanical safety and electromagnetic compatibility (EMC) testing must be performed. If the environments of intended use include locations outside of hospitals and clinics, appropriate higher immunity test levels must be used. Labeling must include appropriate EMC information. (xiv) Information demonstrating immunity from wireless hazards. (3) The clinical performance characteristics of the device for the detection of colon polyps must be established. Demonstration of the performance characteristics must include assessment of positive percent agreement and negative percent agreement compared to a clinically acceptable alternative structural imaging method. (4) Clinician labeling must include: (i) Specific instructions and the clinical and technical expertise needed for the safe use of the device. (ii) A detailed summary of the clinical testing pertinent to use of the device, including the percentage of patients in which a polyp was correctly identified by capsule endoscopy, but also the percent of patients in which the capsule either missed or falsely identified a polyp with respect to the clinically acceptable alternative structural imaging method. (iii) The colon cleansing procedure. (iv) A detailed summary of the device technical parameters. (v) A detailed summary of the device- and procedure-related complications pertinent to use of the device. (vi) An expiration date/shelf life. (5) Patient labeling must include: (i) An explanation of the device and the mechanism of operation. (ii) Patient preparation procedure. (iii) A brief summary of the clinical study. The summary should not only include the percentage of patients in which a polyp was correctly identified by capsule endoscopy, but also the percent of patients in which the capsule either missed or falsely identified a polyp with respect to the clinically acceptable alternative structural imaging method. (iv) A summary of the device- and procedure-related complications pertinent to use of the device. [79 FR 28403, May 16, 2014] § 876.1390 Ingestible gastrointestinal blood detection capsule. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must evaluate: (i) Detection of presence or absence of blood when compared to endoscopic procedures used to detect upper gastrointestinal bleeding; (ii) Capsule excretion and recovery; and (iii) All adverse events. (2) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Dimensional testing must verify device dimensions; (ii) Performance testing must verify functional aspects of the device design; (iii) Battery life testing must be performed to demonstrate the capsule's operating time is not constrained by the battery capacity; (iv) Leak testing must verify device integrity under worst-case clinical conditions; (v) Bite testing must demonstrate that the device can withstand bite forces; (vi) pH resistance testing must evaluate integrity of the capsule when exposed to a physiological relevant range of pH values; (vii) Control and monitoring of capsule bioburden must demonstrate the device does not pose an infection risk; and (viii) Blood detection testing must demonstrate that the device can detect different forms of blood seen under anticipated conditions of use. (3) Software validation, verification, and hazard analysis must be performed. (4) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility testing must be performed. (5) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device. (6) The patient-contacting components of the device must be demonstrated to be biocompatible. (7) Performance testing must support the shelf life of the device by demonstrating continued package integrity and device functionality over the identified shelf life. (8) Physician labeling must include: (i) A detailed summary of the clinical testing pertinent to use of the device, including information on effectiveness and device- and procedure-related complications; (ii) Warning that the device is not a standalone diagnostic device and does not replace clinical decision making; and (iii) A shelf life. (9) Patient labeling must include: (i) An explanation of the device and the mechanism of operation; (ii) The patient preparation procedure; (iii) A brief summary of the clinical study; and (iv) A summary of the device- and procedure-related complications pertinent to use of the device. [91 FR 36521, June 17, 2026] § 876.1400 Stomach pH electrode. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996] § 876.1450 Esophageal tissue characterization system. (a) Identification. (b) Classification. (1) All patient contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics. (3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use. (4) Software verification, validation, and hazard analysis must be performed. (5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed. (6) Performance data must validate the reprocessing instructions for any reusable components of the device. (7) Labeling must include: (i) Specific instructions regarding the proper placement and use of the device; (ii) Instructions for reprocessing of any reusable components; and (iii) An expiration date for single use components. [86 FR 68399, Dec. 2, 2021] § 876.1500 Endoscope and accessories. (a) Identification. (b) Classification Class II (special controls). (2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001; 83 FR 25914, June 5, 2018; 84 FR 71813, Dec. 30, 2019] § 876.1510 Anchored esophageal sheath. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: (i) Testing must verify all dimensions; (ii) Testing must demonstrate that insertion and removal of any device from the anchored esophageal sheath does not damage the shaft wall or exert force that would cause tissue injury; (iii) Testing must demonstrate that the anchoring component can be reliably actuated; (iv) Testing must demonstrate compatibility with any other device that the anchored esophageal sheath is intended to be used with; and (v) Testing must demonstrate device integrity and functionality in simulated gastric conditions under clinically anticipated forces. (3) Simulated use testing using an anatomically accurate gastrointestinal model must demonstrate that: (i) The device can be inserted and removed safely; (ii) The device remains anchored in place; (iii) The device can be safely withdrawn after releasing the anchor; and (iv) The device location and anchoring status can be observed by the intended user. (4) Performance data must demonstrate continued device functionality over the identified shelf life. (5) Labeling must include: (i) Information as to whether the device can be used for foreign body removal or with instruments alongside the endoscope; (ii) Steps needed to prevent injury to the esophagus or gastroesophageal junction (GEJ) during placement, anchoring, and use of the device; (iii) Any visualization steps required to confirm the device's placement prior to and after actuating the anchoring component at the GEJ; (iv) A precaution to avoid excessive force during insertion; (v) Identification of any endoscopes or other devices that have been validated for use with the anchored esophageal sheath; and (vi) An expiration date or shelf life. [90 FR 54232, Nov. 26, 2025] § 876.1520 Gastrointestinal lesion software detection system. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including detection of gastrointestinal lesions and evaluation of all adverse events. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: (i) Standalone algorithm performance testing; (ii) Pixel-level comparison of degradation of image quality due to the device; (iii) Assessment of video delay due to marker annotation; and (iv) Assessment of real-time endoscopic video delay due to the device. (3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device. (4) Performance data must demonstrate electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety testing for any hardware components of the device. (5) Software verification, validation, and hazard analysis must be provided. Software description must include a detailed, technical description including the impact of any software and hardware on the device's functions, the associated capabilities and limitations of each part, the associated inputs and outputs, mapping of the software architecture, and a description of the video signal pipeline. (6) Labeling must include: (i) Instructions for use, including a detailed description of the device and compatibility information; (ii) Warnings to avoid overreliance on the device, that the device is not intended to be used for diagnosis or characterization of lesions, and that the device does not replace clinical decision making; (iii) A summary of the clinical performance testing conducted with the device, including detailed definitions of the study endpoints and statistical confidence intervals; and (iv) A summary of the standalone performance testing and associated statistical analysis. [88 FR 10, Jan. 3, 2023] § 876.1530 Endoscopic light-projecting measuring device. (a) Identification. (b) Classification. (1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate: (i) Visualization during the procedure; (ii) Ease of procedure as reported by the intended user; and (iii) User acceptability of imaging time. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Accuracy validation; (ii) Endoscope compatibility testing; (iii) Battery life testing; (iv) Durability testing; and (v) Light safety testing. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Software verification, validation, and hazard analysis must be performed. (5) Electrical, thermal, and mechanical safety testing must be performed. (6) Performance testing must demonstrate electromagnetic compatibility of the device in the intended use environment. (7) Methods and instructions for reprocessing reusable components must be validated. (8) Labeling must include: (i) Device technical parameters, including a description of the accuracy of the device; (ii) Information regarding endoscope compatibility; (iii) Warning for light hazards and protection for patient and operator; and (iv) Validated reprocessing instructions. [91 FR 36981, June 22, 2026] § 876.1620 Urodynamics measurement system. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998] § 876.1725 Gastrointestinal motility monitoring system. (a) Identification. (b) Classification. § 876.1735 Electrogastrography system. (a) Identification. (b) Classification. (1) The sale, distribution and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter. (2) The labeling must include specific instructions: (i) To describe proper patient set-up prior to the start of the test, including the proper placement of electrodes; (ii) To describe how background data should be gathered and used to eliminate artifact in the data signal; (iii) To describe the test protocol (including the measurement of baseline data) that may be followed to obtain the EGG signal; and (iv) To explain how data results may be interpreted. (3) The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal. (4) Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable. [64 FR 51444, Sept. 23, 1999] § 876.1800 Urine flow or volume measuring system. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63 FR 59228, Nov. 3, 1998] Subpart C—Monitoring Devices § 876.2040 Enuresis alarm. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998] § 876.2050 Prostate lesion documentation system. (a) Identification. (b) Classification. (1) Non-clinical and clinical performance testing must demonstrate the accuracy and reproducibility of the constructed image. (2) Appropriate analysis/testing must validate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety. (3) Appropriate software verification, validation, and hazard analysis must be performed. (4) All elements of the device that may contact the patient must be demonstrated to be biocompatible. (5) Methods and instructions for reprocessing of any reusable components must be properly validated. (6) The labeling must include specific information needed to ensure proper use of the device. [80 FR 72900, Nov. 23, 2015] § 876.2100 Pressure ulcer management tool. (a) Identification. (b) Classification. [86 FR 70735, Dec. 13, 2021] Subpart D—Prosthetic Devices § 876.3350 Penile inflatable implant. (a) Identification. (b) Classification. (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 19658, Apr. 12, 2000] § 876.3500 Penile implant surgical accessories. (a) Identification. (b) Classification. [84 FR 14869, Apr. 12, 2019] § 876.3630 Penile rigidity implant. (a) Identification. (b) Classification. [65 FR 4882, Feb. 2, 2000] § 876.3750 Testicular prosthesis. (a) Identification. (b) Classification. (c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 60 FR 17216, Apr. 5, 1995] Subpart E—Surgical Devices § 876.4020 Fiberoptic light ureteral catheter. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019] § 876.4270 Colostomy rod. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019] § 876.4300 Endoscopic electrosurgical unit and accessories. (a) Identification. (b) Classification. § 876.4310 Endoscopic electrosurgical clip cutting system. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Performance bench testing to evaluate the functionality (including stress, compatibility, usability, and reliability) of the device during use; (ii) Electrical and thermal safety testing; and (iii) Electromagnetic compatibility testing. (2) Animal testing must evaluate tissue damage, including thermal effects, during the clip removal procedure. This testing must also evaluate usability and effectiveness of the device. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device components intended to be provided sterile. (5) Performance data must support shelf life by demonstrating continued sterility of the device (or the sterile components), package integrity, and device functionality over the labeled shelf life. (6) Labeling of the device must include: (i) Instructions for use, and (ii) A shelf life for single use components. [83 FR 27703, June 14, 2018] § 876.4330 Endoscopic pancreatic debridement device. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including evaluation of debridement of walled off pancreatic necrosis and all adverse events. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate the sterility of the patient-contacting components of the device. (4) The patient-contacting components of the device must be demonstrated to be non-pyrogenic. (5) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life. (6) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Testing of rotational speeds and vacuum pressure; (ii) Functional testing including testing with all device components and the ability to torque the device; and (iii) Functional testing in a relevant tissue model to demonstrate the ability to resect and remove tissue. (7) Performance data must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. (8) Software verification, validation, and hazard analysis must be performed. (9) Training must be provided so that upon completion of the training program, the user can resect and remove tissue of interest while preserving non-target tissue. (10) Labeling must include the following: (i) A summary of the clinical performance testing conducted with the device; (ii) Instructions for use, including the creation of a conduit for passage of endoscope and device into a walled off pancreatic necrotic cavity; (iii) Unless clinical performance data demonstrates that it can be removed or modified, a boxed warning stating that the device should not be used in patients with known or suspected pancreatic cancer; (iv) The recommended training for safe use of the device; and (v) A shelf life for any sterile components. [89 FR 72986, Sept. 9, 2024] § 876.4340 High intensity ultrasound system for prostate tissue ablation. (a) Identification. (b) Classification. (1) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Characterization of acoustic pressure and power output at clinically relevant levels; (ii) Measurement of targeting accuracy and reproducibility of high intensity ultrasound output; (iii) Ultrasound-induced heating verification testing at target and non-target tissues; (iv) Electrical safety testing; and (v) Electromagnetic compatibility testing. (2) Software verification, validation, and hazard analysis must be performed. (3) The elements of the device that may contact the patient's mucosal tissue must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device components that contact the patient's mucosal tissue. (5) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the identified shelf life. (6) Performance data must support the instructions for reprocessing all reusable components. (7) In vivo (8) Clinical testing must document the adverse event profile, provide evidence of prostatic ablation, and demonstrate that the device performs as intended under anticipated conditions of use. (9) Training must be provided so that upon completion of the training program, the physician can: (i) Use all safety features of the device; (ii) Accurately target the high intensity ultrasound energy within the desired region of the prostate; and (iii) Perform the ablation procedure in a manner that minimizes damage to non-target tissues. (10) Labeling must include: (i) A section that summarizes the clinical testing results, including the adverse event profile and evidence of prostate ablation achieved; and (ii) An expiration date or shelf life for single use components. [82 FR 45727, Oct. 2, 2017] § 876.4350 Fluid jet system for prostate tissue removal. (a) Identification. (b) Classification. (1) Clinical performance testing must evaluate the following: (i) All adverse events associated with the device, and (ii) Improvement in lower urinary tract symptoms (LUTS). (2) Physician training must be provided that includes: (i) Information on key aspects and use of the device, and (ii) Information on how to override or stop resection. (3) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues. (4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and (ii) High pressure fluid jet verification testing at target and non-target tissues. (5) Software verification, validation, and hazard analysis must be performed. (6) The patient-contacting elements of the device must be demonstrated to be biocompatible. (7) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device. (8) Performance data must demonstrate the sterility of the patient-contacting components of the device. (9) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (10) Performance data must validate the instructions for reprocessing and reliability of reusable components. (11) Labeling must include the following: (i) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS; (ii) A shelf life for single use components; (iii) A use life for reusable components; and (iv) Reprocessing instructions for reusable components. [83 FR 27897, June 15, 2018] § 876.4370 Gastroenterology-urology evacuator. (a) Identification. (b) Classification. (2) Class I for the gastroenterology-urology evacuator when manually powered. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 63 FR 59228, Nov. 3, 1998] § 876.4400 Hemorrhoidal ligator. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019] § 876.4410 Endoscopic traction device. (a) Identification. (b) Classification. (1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate: (i) Perforation, bleeding, and mucosal injury; (ii) Ease of insertion and removal of the device; (iii) Visualization during the procedure; and (iv) Ease of procedure as reported by the intended user. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: (i) Device deployment and detachment; (ii) Ability to retract tissue; (iii) Tensile strength; (iv) Potential for laceration caused by the device or procedure using the device; (v) Dimensional verification; and (vi) For devices that contain a magnet, magnet strength verification and safety assessment. (3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device. (4) Performance data must demonstrate the sterility of the patient-contacting components of the device. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life. (7) Labeling must include: (i) The recommended training for safe use of the device; (ii) Anatomical locations and lesion sizes that have been demonstrated to be safe to use with the device; and (iii) A shelf life. [91 FR 36983, June 22, 2026] § 876.4480 Electrohydraulic lithotriptor. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, 2000] § 876.4500 Mechanical lithotriptor. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019] § 876.4530 Gastroenterology-urology fiberoptic retractor. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 66 FR 38801, July 25, 2001] § 876.4560 Ribdam. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 66 FR 38801, July 25, 2001] § 876.4590 Interlocking urethral sound. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001] § 876.4620 Ureteral stent. (a) Identification. (b) Classification. § 876.4630 Ureteral stent accessories. (a) Identification. (b) Classification. [84 FR 14870, Apr. 12, 2019] § 876.4650 Water jet renal stone dislodger system. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998] § 876.4680 Ureteral stone dislodger. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998] § 876.4730 Manual gastroenterology-urology surgical instrument and accessories. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 66 FR 38801, July 25, 2001; 82 FR 12171, Mar. 1, 2017] § 876.4770 Urethrotome. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019] § 876.4890 Urological table and accessories. (a) Identification. (b) Classification. (2) Class I for the manually powered table and accessories, and for stirrups for electrically powered table. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63 FR 59228, Nov. 3, 1998; 66 FR 38801, July 25, 2001] Subpart F—Therapeutic Devices § 876.5010 Biliary catheter and accessories. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019] § 876.5011 Metallic biliary stent system for benign strictures. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate or provide the following: (i) The ability to safely place and subsequently remove the stent after the maximum labeled indwell period. (ii) All adverse event data including bile duct obstruction and trauma to the bile duct. (iii) The stent resolves strictures during the maximum labeled indwell period. (iv) Stricture resolution is maintained post-stent removal. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: (i) Corrosion testing to demonstrate that the stent maintains its integrity during indwell and does not release potentially toxic levels of leachables. (ii) Stent dimensional testing supports the intended use. (iii) Compression and expansion forces must be characterized. (iv) The delivery catheter must deliver the stent to the intended location and the stent must not be adversely impacted by the delivery catheter during deployment and catheter withdrawal. (v) The delivery system must withstand clinically anticipated forces. (vi) Compatibility in a magnetic resonance environment. (3) All patient contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device components intended to be provided sterile. (5) Shelf life testing must demonstrate that the device maintains its performance characteristics and that packaging maintains sterility for the duration of the labeled shelf life. (6) Labeling for the device must include: (i) A detailed summary of the clinical testing including device effectiveness, and device- and procedure-related adverse events. (ii) Appropriate warning(s) to accurately ensure usage of the device for the intended patient population. (iii) Shelf life. (iv) Compatibility information for use in the magnetic resonance environment. (v) Stent foreshortening information supported by dimensional testing. [81 FR 45231, July 13, 2016] § 876.5012 Biliary stent, drain, and dilator accessories. (a) Identification. (b) Classification. [84 FR 14870, Apr. 12, 2019] § 876.5015 Pancreatic drainage stent and delivery system. (a) Identification. (b) Classification. (1) The device and elements of the delivery device that may contact the patient must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of patient-contacting components of the device. (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the requested shelf life. (4) Non-clinical testing data must demonstrate that the stent and delivery system perform as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Deployment testing of the stent and delivery system must be conducted under simulated use conditions. (ii) Removal force testing must be conducted. The removal force testing must demonstrate that the stent can be safely removed, and that the stent will remain in place when subjected to forces encountered during use. (iii) Expansion force testing must be conducted. The expansion force must demonstrate that the forces exerted by the stent will not damage the tissue surrounding the stent. (iv) Compression force testing must be conducted. The compression force must demonstrate that the stent will withstand the forces encountered during use. (v) Dimensional verification testing must be conducted. (vi) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use. (vii) Fatigue testing must be conducted. Material strength must demonstrate that the stent will withstand forces encountered during use. (viii) Corrosion testing must be conducted. Corrosion resistance must demonstrate that the stent will withstand conditions encountered during use. (5) Non-clinical testing must evaluate the compatibility of the stent in a magnetic resonance (MR) environment. (6) Well-documented clinical experience must demonstrate safe and effective use, and capture any adverse events observed during clinical use. (7) Labeling must include the following: (i) Appropriate instructions, warnings, cautions, limitations, and information related to the safe use of the device, including deployment of the device, maintenance of the drainage lumen, and removal of the device. (ii) A warning that the safety and patency of the stent has not been established beyond the duration of the documented clinical experience. (iii) Specific instructions and the qualifications and clinical training needed for the safe use of the device, including deployment of the device, maintenance of the drainage lumen, and removal of the device. (iv) Information on the patient population for which the device has been demonstrated to be effective. (v) A detailed summary of the clinical experience pertinent to use of the device. (vi) A detailed summary of the device technical parameters. (vii) A detailed summary of the device- and procedure-related complications pertinent to use of the device. (viii) An expiration date/shelf life. [79 FR 30724, May 29, 2014] § 876.5020 External penile rigidity devices. (a) Identification. (b) Classification. [69 FR 77623, Dec. 28, 2004] § 876.5021 Non-medicated topical formulation for treatment of erectile dysfunction. (a) Identification. (b) Classification. (1) The device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Condom compatibility; (ii) Temperature profile evaluation; and (iii) Verification of device specifications. (3) Performance data must support the shelf life of the device by demonstrating the device meets its specifications over the identified shelf life. (4) Labeling must include: (i) Information regarding compatibility with condoms; (ii) An expiration date; (iii) A statement that the product is not a contraceptive; (iv) Information for the correct diagnosis of erectile dysfunction; and (v) Dosage and frequency of use. [91 FR 46834, July 27, 2026] § 876.5025 Vibrator for climax control of premature ejaculation. (a) Identification. (b) Classification. (1) The labeling must include specific instructions regarding the proper placement and use of the device. (2) The portions of the device that contact the patient must be demonstrated to be biocompatible. (3) Appropriate analysis/testing must demonstrate electromagnetic compatibility safety, electrical safety, and thermal safety of the device. (4) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use. [80 FR 30355, May 28, 2015, as amended at 84 FR 71814, Dec. 30, 2019] § 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation. (a) Identification. (b) Classification. (1) The device must be demonstrated to be biocompatible. (2) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Mechanical performance; (ii) Electrical stimulation parameters; and (iii) Battery performance. (4) Performance testing must support shelf life by demonstrating continued device functionality over the identified shelf life. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include: (i) Specific instructions regarding safe placement and correct use of the device; (ii) Warning(s) against use by patients with active implanted medical devices; and (iii) A shelf life. [87 FR 34166, Apr. 5, 2022] § 876.5030 Continent ileostomy catheter. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 66 FR 38801, July 25, 2001] § 876.5090 Suprapubic urological catheter and accessories. (a) Identification. (b) Classification. (2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001] § 876.5100 Suprapubic catheter accessories. (a) Identification. (b) Classification. [84 FR 14870, Apr. 12, 2019] § 876.5130 Urological catheter and accessories. (a) Identification. (b) Classification. (2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001] § 876.5140 Urethral insert with pump for bladder drainage. (a) Identification. (b) Classification. (1) The elements of the device that may contact the urinary tract must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of the device components that contact the urinary tract. (3) Performance data must support shelf life by demonstrating continued sterility of the device (or the sterile components), package integrity, and device functionality over the requested shelf life. (4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Urine flow rate testing. (ii) Valve integrity testing. (iii) Bladder neck retention force testing. (iv) Pump/valve endurance testing. (v) Encrustation testing. (vi) Remote control reliability, mechanical integrity, and battery life testing. (5) Clinical testing must demonstrate safe and effective use, document the device acceptance rate and the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. (6) Labeling must include: (i) Specific instructions, contraindications, warnings, cautions, limitations, and the clinical training needed for the safe use of the device. (ii) Statement of the maximum insert indwelling period. (iii) Information on the patient education and support program prior to and during initial device use. (iv) Information on the patient population for which the device has been demonstrated to be safe and effective. (v) Information on how the device operates and the recommended treatment regimen. (vi) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device. (vii) An expiration date/shelf life. (7) Patient labeling must be provided and must include: (i) Relevant contraindications, warnings, precautions, and adverse events/complications. (ii) Information on how the device operates and the recommended treatment regimen. (iii) Information on the patient education and support program prior to and during initial device use. (iv) Information on the patient population for which there is clinical evidence of safety and effectiveness. (v) The potential risks and benefits associated with the use of the device. (vi) Post-insertion care instructions. (vii) Alternative treatments. [80 FR 18309, Apr. 6, 2015] § 876.5160 Urological clamp. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317, Jan. 14, 2000; 84 FR 71814, Dec. 30, 2019] § 876.5210 Enema kit. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317, Jan. 14, 2000; 90 FR 55985, Dec. 4, 2025] § 876.5220 Colonic irrigation system. (a) Identification. (b) Classification. (2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being. (c) Date PMA or notice of completion of a PDP is required. [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, 1996] § 876.5250 Urine collector and accessories. (a) Identification. (1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and (2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence. (b) Classification Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. (2) Class I (general controls). [48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998; 65 FR 2317, Jan. 14, 2000; 66 FR 38802, July 25, 2001; 73 FR 34860, June 19, 2008; 90 FR 55985, Dec. 4, 2025] § 876.5270 Implanted electrical urinary continence device. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, 1996] § 876.5280 Implanted mechanical/hydraulic urinary continence device. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 57731, Sept. 26, 2000] § 876.5290 Implanted mechanical/hydraulic urinary continence device surgical accessories. (a) Identification. (b) Classification. [84 FR 14870, Apr. 12, 2019] § 876.5305 Implanted tibial electrical urinary continence device. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following testing must be conducted: (i) Electrical performance testing of the device must be conducted to validate the specified electrical output and duration of stimulation of the device; and (ii) Testing must verify the implant can withstand clinically relevant forces during and after implantation. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate the sterility of the patient-contacting components of the device. (4) Performance data must support the shelf life of the device by demonstrating continued sterility of patient-contacting components, package integrity, and device functionality over the identified shelf life. (5) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, thermal safety, and wireless performance of the device. (6) Software verification, validation, and hazard analysis must be performed. (7) Performance testing must evaluate the compatibility of the device in a magnetic resonance environment. (8) Labeling for the device must include: (i) A contraindication against use during pregnancy; (ii) A contraindication against using the device in men who have Benign Prostatic Hyperplasia (BPH) or other lower urinary tract obstructions; (iii) A detailed summary of the device technical parameters and the typical course of treatment; (iv) Device- and procedure-related adverse events pertinent to use of the device; and (v) A shelf life for any sterile components. (9) Patient labeling must include: (i) Post-operative care instructions to avoid infection and inflammation of the surgical site; (ii) Instructions to avoid overstimulation related nerve and tissue damage; (iii) Instructions to avoid mechanical injuries to nerve and tissue caused by the implanted component; (iv) Instructions for reprocessing/cleaning of any reusable components; (v) Clinical performance reported by relevant subgroups; (vi) The risks and benefits associated with use of the device; (vii) Information on the typical course of treatment; (viii) Instructions to avoid pain and discomfort; and (ix) Instructions to avoid interference with other medical devices. [91 FR 57506, Sept. 10, 2026] § 876.5310 Nonimplanted, peripheral electrical continence device. (a) Identification. (b) Classification. (1) That sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter. (2) That the labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based. [65 FR 18237, Apr. 7, 2000] § 876.5320 Nonimplanted electrical continence device. (a) Identification. (b) Classification. § 876.5330 Transcutaneous electrical continence device. (a) Identification. (b) Classification. (1) Non-clinical performance testing must characterize the electrical stimulation, including the following: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density. (2) The patient-contacting materials must be demonstrated to be biocompatible. (3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) Labeling must include the following: (i) Instructions for use, including specific instructions regarding the proper placement of electrodes; (ii) A summary of electrical stimulation parameters; and (iii) Cleaning instructions and reuse information. [86 FR 73971, Dec. 29, 2021] § 876.5340 Nonimplanted nerve stimulator for functional abdominal pain relief. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed. (3) Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) Sterility testing of the percutaneous components of the device must be performed. (6) Shelf life testing must be performed to demonstrate continued sterility, package integrity, and device functionality over the labeled shelf life. (7) Labeling must include the following: (i) A detailed summary of the device technical parameters; (ii) A warning stating that the device is only for use on clean, intact skin; (iii) Instructions for use, including placement of the device on the patient; and (iv) A shelf life. [86 FR 71143, Dec. 15, 2021] § 876.5360 Laparoscopic gastrointestinal sizing tool. (a) Identification. (b) Classification. (1) Performance testing must demonstrate that the sizing tool performs as intended under anticipated conditions of use. Performance testing must include the following: (i) Trocar compatibility, which includes shaft bending force characterization; (ii) Joint strength tensile testing; (iii) Distal loop extension/retraction force characterization; (iv) Material selection analysis, which includes corrosion and visual inspection; and (v) Accuracy of the dimensional measurement. (2) Performance testing must support the sterility and/or reprocessing and shelf life of the patient-contacting components of the device. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Labeling of the device must include the following: (i) A statement regarding metal allergies if the device is made from metallic components; (ii) Specific instructions for proper device use including information regarding the following: (A) Inspection of device prior to use; (B) Surgical access techniques or methodologies; (C) Instructions for avoiding structural damage to vagus nerve bundle; (D) Trocar compatibility; (E) Sizing methodology; and (F) Minimum and maximum dimensional parameters that the device is capable of measuring. (iii) Identification of the associated parent device with which the sizing tool has been demonstrated to be compatible; and (iv) An expiration date. [90 FR 40730, Aug. 21, 2025] § 876.5365 Esophageal dilator. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019] § 876.5450 Rectal dilator. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38802, July 25, 2001] § 876.5470 Ureteral dilator. (a) Identification. (b) Classification. § 876.5510 Temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia. (a) Identification. (b) Classification. (1) Clinical performance testing with the device under anticipated conditions of use must evaluate improvement in urinary outflow symptoms and document the adverse event profile. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate the sterility of the patient-contacting components of the device. (4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life. (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Deployment and removal; and (ii) Mechanical strength. (6) Labeling must include: (i) Instructions for use, including the recommended training for safe use of the device; (ii) A summary of the clinical performance testing conducted with the device, including device- and procedure-related adverse events; and (iii) A shelf life. [90 FR 22636, May 29, 2025] § 876.5520 Urethral dilator. (a) Identification. (b) Classification. (2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38802, July 25, 2001; 84 FR 71814, Dec. 30, 2019] § 876.5530 Implantable transprostatic tissue retractor system. (a) Identification. (b) Classification. (1) The elements of the device that may contact the patient must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of the patient-contacting components of the device. (3) Performance data must support shelf life by demonstrating continued sterility of the device (of the patient-contacting components), package integrity, and device functionality over the requested shelf life. (4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Deployment testing must be conducted. (ii) Mechanical strength must be conducted. (iii) Resistance-to-degradation testing must be conducted. (5) Non-clinical testing must evaluate the compatibility of the device in a magnetic resonance environment. (6) In vivo testing must demonstrate safe and effective use, assess the impact of the implants on the ability to perform subsequent treatments, document the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Deployment testing must be conducted. (ii) Implant migration must be conducted. (7) Labeling must bear all information required for safe and effective use of the device, and must include: (i) Specific instructions, warnings, cautions, limitations, and the clinical training needed for the safe use of the device. (ii) Information on the patient population for which the device has been demonstrated to be effective. (iii) A detailed summary of the device technical parameters. (iv) Information on how the device operates and the typical course of treatment. (v) An expiration date/shelf life. (vi) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device. [79 FR 43249, July 25, 2014] § 876.5540 Blood access device and accessories. (a) Identification. (1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device. (2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents). (b) Classification. (i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided. (ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated. (B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided. (C) Priming volumes must be established. (D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use. (E) Air leakage testing and liquid leakage testing must be conducted. (F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage. (G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern. (H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established. (iii) Performance data must demonstrate the sterility of the device. (iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing. (v) Labeling of implanted blood access devices for hemodialysis must include the following: (A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated. (B) Labeling must specify the forward and reverse recirculation rates. (C) Labeling must provide the arterial and venous priming volumes. (D) Labeling must specify an expiration date. (E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device. (F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient. (G) Labeling must include a patient implant card. (H) The labeling must contain comprehensive instructions for the following: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 (vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following: (A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port. (B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device. (C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use. (vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following: (A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied. (B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties. (C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens. (D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness. (viii) The following must be included for A-V shunt cannulae (with vessel tips): (A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply. (B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation. (C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use. (2) Class II (performance standards) for the nonimplanted blood access device. (3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section. (4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 FR 1122, Jan. 16, 1996; 66 FR 38802, July 25, 2001; 79 FR 43245, July 25, 2014] § 876.5550 Prostatic artery embolization device. (a) Identification. (b) Classification. (1) The device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Evaluation of suitability for injection through catheters intended for use in embolization; and (ii) Evaluation of the size distribution of the device. (3) Performance data must support the sterility and pyrogenicity of the device. (4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (5) Clinical data must evaluate post-embolization damage due to non-target embolization under anticipated use conditions. (6) The labeling must include: (i) Specific instructions on safe device preparation and use; (ii) The device shelf life; (iii) Data regarding urinary retention; and (iv) Data regarding post-prostatic artery embolization syndrome. [82 FR 52651, Nov. 14, 2017] § 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis. (a) Identification. (b) Classification. § 876.5630 Peritoneal dialysis system and accessories. (a) Identification. (2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments. (3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles. (4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019] § 876.5665 Water purification system for hemodialysis. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019] § 876.5820 Hemodialysis system and accessories. (a) Identification. (1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray. (b) Classification. (2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 66 FR 38802, July 25, 2001] § 876.5830 Hemodialyzer with disposable insert (Kiil type). (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988] § 876.5860 High permeability hemodialysis system. (a) Identification. (1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf (2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors). (b) Classification. (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.” [65 FR 17145, Mar. 31, 2000] § 876.5861 Pediatric continuous renal replacement therapy system. (a) Identification. (b) Classification. (1) Clinical performance testing must confirm the safety and the accuracy, precision, and reproducibility of the non-clinical performance data under anticipated conditions of use. (2) Usability testing must demonstrate that a user can correctly use the hemodialysis delivery device based solely on reading the instructions for use. (3) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Hemodialysis delivery system performance testing must include: (A) Fluid flow accuracy testing; and (B) Functional testing of system components including sensors, pumps, and scales to acceptance criteria. (ii) Hemodialyzer performance testing must include: (A) Ultrafiltration; (B) Blood and dialysate pressure drop; (C) Clearance rates; (D) Sieving coefficients; (E) Mechanical hemolysis; (F) Structural integrity; (G) Blood compartment integrity; (H) Volume of the blood compartment; and (I) Chemical analysis of the dialyzer membrane. (iii) Blood tubing set performance testing must include: (A) Pressure leak testing; (B) Worst-case endurance testing; (C) Priming volume assessment; (D) Tensile testing of joints and materials of all tubing segments; (E) Pressure transducer leak testing; (F) Clamp occlusion; (G) Mechanical hemolysis; and (H) Kink testing. (4) Software verification, validation, and hazard analysis must be performed. (5) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and wireless compatibility of the device. (6) The tissue-contacting components of the device must be demonstrated to be biocompatible. (7) Performance data must demonstrate the sterility of the patient-contacting components of the device. (8) Performance data must validate the reprocessing instructions for the reusable components of the device. (9) The patient-contacting components of the device must be demonstrated to be non-pyrogenic. (10) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (11) Device labeling must include: (i) Hemodialysis delivery system labeling must provide detailed information regarding the safe use of the dialysis machine, including: (A) Overall description of the device and individual components or accessories labeled for use with the delivery system; (B) Description of the safety-related components included in the system; (C) Identification of operational parameters; (D) Alarms and troubleshooting information; (E) Cleaning, disinfection, and preventative maintenance procedures; and (F) A statement that the device is intended for use by operators trained in the administration of continuous renal replacement therapy and in the management of its complications. (ii) Hemodialyzer labeling must include: (A) Description of compatibility; (B) Shelf life; (C) Storage conditions; (D) Instructions for the preparation of the hemodialyzer, initiation of dialysis, troubleshooting, and discontinuance of dialysis; (E) Membrane surface area, priming (blood) volume, maximum transmembrane pressure, maximum blood flow and maximum dialysate rate for each model; (F) Summary of the in vitro performance data; and (G) A non-pyrogenic statement. (iii) Blood tubing set labeling must provide detailed information regarding the safe use of the device, including: (A) Description of compatibility; (B) Shelf life; (C) Storage conditions; (D) Identification of the components in the package; (E) Total length of the arterial and venous tubing sets; (F) Outer diameter (OD) of the pump segment; (G) Priming volume; (H) Identification of the hemodialysis delivery systems which are compatible with the blood tubing set; (I) Identification of the largest gauge needle that can be used with the injection port, if applicable; and (J) Identification of the maximum operating pressures for the transducer protectors. [89 FR 75496, Sept. 16, 2024] § 876.5862 Hemodialyzer with expanded solute removal profile. (a) Identification. (b) Classification. (1) Clinical performance testing under anticipated conditions of use must evaluate the solute removal profile and document all adverse events. (2) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Ultrafiltration; (ii) Blood and dialysate pressure drop; (iii) Clearance rates; (iv) Sieving coefficients; (v) Mechanical hemolysis; (vi) Structural integrity; (vii) Blood compartment integrity; (viii) Volume of the blood compartment; and (ix) Endotoxin retention of the dialyzer membrane. (3) The tissue-contacting components of the device must be demonstrated to be biocompatible. Biocompatibility evaluation must include a chemical analysis of the dialyzer membrane. (4) Performance data must demonstrate the sterility of the patient-contacting components of the device. (5) The patient-contacting components of the device must be demonstrated to be non-pyrogenic. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (7) Device labeling must include: (i) Shelf life; (ii) Storage conditions; (iii) Instructions for the preparation of the hemodialyzer, initiation of dialysis, troubleshooting, and discontinuance of dialysis; (iv) Membrane surface area, priming (blood) volume, maximum transmembrane pressure, maximum blood flow and maximum dialysate rate for each model; (v) A non-pyrogenic statement; (vi) A summary of the in vitro performance data, provided in tabular form; and (vii) A summary of the clinical performance data. [89 FR 72716, Sept. 6, 2024] § 876.5870 Sorbent hemoperfusion system. (a) Identification. (b) Classification. (i) The device must be demonstrated to be biocompatible; (ii) Performance data must demonstrate the mechanical integrity of the device (e.g., tensile, flexural, and structural strength), including testing for the possibility of leaks, ruptures, release of particles, and/or disconnections under anticipated conditions of use; (iii) Performance data must demonstrate device sterility and shelf life; (iv) Bench performance testing must demonstrate device functionality in terms of substances, toxins, and drugs removed by the device, and the extent that these are removed when the device is used according to its labeling, and to validate the device's safeguards; (v) A summary of clinical experience with the device that discusses and analyzes device safety and performance, including a list of adverse events observed during the testing, must be provided; (vi) Labeling must include the following: (A) A detailed summary of the device-related and procedure-related complications pertinent to the use of the device; (B) A summary of the performance data provided for the device, including a list of the drugs and/or poisons the device has been demonstrated to remove, and the extent for removal/depletion; and (vii) For those devices that incorporate electrical components, appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device. (2) Class III (premarket approval) when the device is intended for the treatment of hepatic coma and metabolic disturbances. (c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. [79 FR 3094, Jan. 17, 2014] § 876.5880 Isolated kidney perfusion and transport system and accessories. (a) Identification. (b) Classification. § 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications. (a) Identification. (b) Classification. [66 FR 27025, May 16, 2001] § 876.5895 Ostomy irrigator. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019] § 876.5900 Ostomy pouch and accessories. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 66 FR 38802, July 25, 2001] § 876.5920 Protective garment for incontinence. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 66 FR 38802, July 25, 2001; 90 FR 55985, Dec. 4, 2025] § 876.5930 Rectal control system. (a) Identification. (b) Classification. (1) Clinical testing must document the device acceptance data and the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. (2) The elements of the device that contact vaginal tissue must be demonstrated to be biocompatible. (3) The cleaning and disinfection instructions for the device must be validated. (4) Non-clinical (bench) testing must demonstrate that the device performs as intended under anticipated conditions of use. (5) Non-clinical (bench) testing must demonstrate that the device does not: (i) Enhance the growth of Staphylococcus aureus. (ii) Increase production of Toxic Shock Syndrome Toxin-1 by S. aureus. (iii) Alter the growth of normal vaginal flora. (6) Labeling must include: (i) Specific instructions, contraindications, warnings, cautions, limitations, and the clinical training needed for the safe use of the device. (ii) The intended patient population and the intended use environment. (iii) Information on how the device is to be fitted, how the device operates, and recommendations on device maintenance. (iv) A detailed summary of the clinical testing pertinent to the use of the device, including a summary of the device- and procedure-related complications or adverse events related to use of the device, as well as relevant safety and performance information. (7) Patient labeling must be provided and must include: (i) Relevant contraindications, warnings, precautions, and adverse events/complications. (ii) Information on how the device operates and the recommended device maintenance ( i.e. (iii) Information on the patient population for which there was a favorable benefit/risk assessment. (iv) The potential risks and benefits associated with the use of the device. [80 FR 30933, June 1, 2015] § 876.5940 Orally ingested transient device for constipation. (a) Identification. (b) Classification. (1) Clinical data must demonstrate the device performs as intended and evaluate the following: (i) Treatment of constipation; and (ii) All adverse events. (2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Dimensional testing must verify device dimensions; (ii) Performance bench testing must verify functional aspects of the device design; (iii) Leak testing must verify device integrity under worst case clinical conditions; (iv) Bite testing must demonstrate that the device can withstand bite forces; (v) pH resistance testing must evaluate integrity of the capsule when exposed to a physiological relevant range of pH values; and (vi) Bioburden testing must demonstrate the device does not pose an infection risk throughout the labeled shelf life. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life. (5) Software validation, verification, and hazard analysis must be performed. (6) Electrical safety and electromagnetic compatibility testing must be performed for any electrical components of the device. (7) Labeling for the device must include: (i) A summary of clinical data for the device, including a discussion of adverse events and clinical benefit; and (ii) A shelf life. [91 FR 32349, June 1, 2026] § 876.5955 Peritoneo-venous shunt. (a) Identification. (b) Classification. (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and (3) Backflow specification and testing to prevent reflux of blood into the shunt. [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, 2000] § 876.5960 Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions. (a) Identification. (b) Classification. (1) Clinical data must be provided to fulfill the following: (i) Describe a model of therapy for the indicated gastrointestinal conditions; (ii) Validate the model of therapy as implemented by the device using a clinically defined endpoint; and (iii) Evaluate all adverse events. (2) Software must be described in detail in the software requirements specification and software design specification. Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model. (3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device. (4) Labeling: (i) Labeling must include instructions for use, including images that demonstrate how to interact with the device; (ii) Patient and physician labeling must list the minimum operating system requirements that support the software of the device; (iii) Patient and physician labeling must include a warning that the device is not intended for use in lieu of a standard therapeutic intervention or to represent a substitution for the patient's medication; (iv) Patient and physician labeling must include a warning to seek medical care if a patient has feelings or thoughts of harming themselves or others; and (v) Physician and patient labeling must include a summary of the clinical testing with the device. [88 FR 3636, Jan. 20, 2023] § 876.5970 Hernia support. (a) Identification. (b) Classification. [48 FR 53023, Nov. 23, 1983, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001; 90 FR 55985, Dec. 4, 2025] § 876.5980 Gastrointestinal tube and accessories. (a) Identification. (b) Classification. (2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9. [49 FR 573, Jan. 5, 1984, as amended at 65 FR 2317, Jan. 14, 2000; 65 FR 76932, Dec. 8, 2000; 84 FR 71814, Dec. 30, 2019] § 876.5981 Oral removable palatal space occupying device for weight management and/or weight loss. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows: (i) Mechanical testing must demonstrate that the device performs as intended for the labeled use life and does not create forces that result in movement of teeth and damage to teeth. (ii) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended. (iii) Software verification and validation must demonstrate that the device performs as intended. (iv) Battery testing must demonstrate that the device battery performs as intended. (3) Clinical performance testing must demonstrate the device performs as intended and must include an evaluation for choking. (4) Device labeling must address the following: (i) Patient labeling must state: (A) The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss; (B) Treatment must be offered in combination with a behavioral modification program; (C) Instructions on how to use the device as intended; and (D) The use life of the device. (ii) Physician labeling must state: (A) The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss; (B) Treatment must be offered in combination with a behavioral modification program; (C) Instructions on how to use the device as intended; and (D) The use life of the device. (5) Training must be provided to health professionals that includes procedures for determining a patient's oral health status, instructions for making the palatal mold, and assessment of issues with the device that may require service by the manufacturer. [82 FR 35069, July 28, 2017] § 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows: (i) Performance bench testing in a simulated use model must evaluate device disintegration and device hydration state throughout the gastrointestinal tract; (ii) Bioburden and moisture content assessments must evaluate device infection risk throughout the labeled shelf life; and (iii) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life. (3) Clinical performance testing must demonstrate the device performs as intended and evaluate the following: (i) Weight change; (ii) All adverse events, including obstruction, dilation, diarrhea, constipation, and dehydration; and (iii) Interaction with representative medications. (4) Physician and patient device labeling must state: (i) The clinical benefit of the device as assessed by using percent total body weight loss; (ii) Treatment must be offered in combination with diet and exercise; (iii) Instructions on how to use the device as intended including how to avoid interaction with medication; and (iv) The shelf life of the device. [86 FR 70372, Dec. 10, 2021] § 876.5983 Endoscopic suturing device for altering gastric anatomy for weight loss. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use and evaluate the following: (i) Weight change; and (ii) All adverse events. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Performance bench testing in a simulated use model must verify functional aspects of the device design and support device durability during clinical use; (ii) Dimensional specifications must be verified; and (iii) Tensile strength testing must be performed for all articulating components. (3) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life. (4) Performance data must demonstrate the sterility of the patient-contacting components of the device. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Training must be provided so that, upon completion of the training program, the user can use the device correctly to approximate tissue to alter the gastric anatomy for the purpose of weight loss with minimal impact to the safety of the patient. (7) Labeling must include: (i) A summary of clinical performance testing with the device, including a discussion of adverse events and clinical benefit reported as percent total body weight loss; and (ii) A shelf life. [91 FR 31661, May 28, 2026] § 876.5985 Enzyme packed cartridge. (a) Identification. ex vivo (b) Classification. (1) The patient contacting components of the device must be demonstrated to be biocompatible. (2) In vivo (3) Non-clinical testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: (i) Mechanical testing to demonstrate that the device can withstand clinical forces; (ii) Flow rate and leakage testing to demonstrate that the device does not impede the flow of enteral formula; (iii) Demonstration of enzymatic effect on intended macronutrient; (iv) The amount of enzyme that exits the cartridge must be characterized; (v) Validation that the device does not adversely impact the nutritional composition of enteral formula; and (vi) Validation that the device does not impede flow alarms on enteral feeding pumps. (4) Human factors testing must be performed to characterize use error risks. (5) Performance data must support shelf life by demonstrating package integrity and device functionality over the identified shelf life. (6) Labeling must include the following: (i) A detailed summary of in vivo (ii) A detailed summary of compatible formulas that is supported by non-clinical testing, including the expected enzymatic conversion as a percentage; (iii) Detailed instructions on how to place the device into an enteral feeding circuit; (iv) A warning regarding the possibility for misconnections; and (v) Expiration date or shelf life. (7) Patient labeling must be provided and must include: (i) Relevant warnings, precautions, adverse effects, and complications; (ii) A description of the device and how it operates; (iii) Instructions on how to correctly use the device; and (iv) The benefits and risks associated with the use of the device. [82 FR 47971, Oct. 16, 2017] § 876.5990 Extracorporeal shock wave lithotripter. (a) Identification. (b) Classification. [65 FR 48612, Aug. 9, 2000]

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