PART 878—GENERAL AND PLASTIC SURGERY DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 53 FR 23872, June 24, 1988, unless otherwise noted. Editorial Note: Nomenclature changes to part 878 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 878.1 Scope. (a) This part sets forth the classification of general and plastic surgery 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 cannot show merely that the device is accurately described by the section title and identification provision of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87 of this chapter. (c) To avoid duplicative listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed in one subpart only. (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.. [53 FR 23872, June 24, 1988, as amended at 67 FR 77676, Dec. 19, 2002; 78 FR 18233, Mar. 26, 2013] § 878.3 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 paragraphs (b) and (c) 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. (c) A device identified in a regulation in this part that is classified into class III and that is subject to the transitional provisions of section 520(l) of the act is automatically classified by statute into class III and must have an approval under section 515 of the act before being commercially distributed. Accordingly, the regulation for such a class III transitional 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. § 878.9 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 2317, Jan. 14, 2000] Subpart B—Diagnostic Devices § 878.1800 Speculum and accessories. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001] § 878.1820 Software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer. (a) Identification. e.g., (b) Classification. (1) Data obtained from premarket clinical performance validation testing, or a combination of premarket clinical performance validation testing and post-market surveillance (in accordance with paragraph (b)(2) of this section), must: (i) Demonstrate superior accuracy of device-aided users' diagnostic characterization of the indicated lesions compared to the accuracy of unaided users in the intended patient population and under anticipated conditions of use; (ii) Include an evaluation of patients across risk factors (including age, body site, skin phototype, and other clinical factors as applicable) that represent the intended patient population under anticipated conditions of use; and (iii) Include standalone device performance testing that demonstrates the accuracy of the device output relative to ground truth in the intended patient population and under anticipated conditions of use, including the following: (A) Testing must demonstrate at least 90% sensitivity of the device output for lesions with high metastatic potential, or an alternative clinical consideration must be provided to justify lower sensitivity. Clinical justification must be provided to support the reported specificity. (B) Lesions must be selected by representative users ( e.g., (C) Justification must be provided to support the determination of ground truth. (D) Testing must include a representative range of individuals with different risk factors (including age, body site, skin phototype, and other clinical factors as applicable), and analysis of standalone performance must include subgroup analysis by relevant risk factors. (2) Data obtained from post-market surveillance must demonstrate, in consideration of the premarket data obtained in accordance with paragraph (b)(1) of this section, that the device performs in accordance with paragraph (b)(1) of this section, unless FDA determines, based on the totality of the premarket data, that data from post-market surveillance is not required to demonstrate that the device performs as intended. Such post-market surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with paragraph (b)(1) of this section), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including compatibility testing of the device software with specific signal or image acquisition hardware. Testing must include a description of compatible hardware and processes, pre-specified compatibility testing protocols, and dataset(s). (4) Performance testing must demonstrate device precision, including repeatability and reproducibility of device performance, across operators and challenging use conditions. (5) Performance testing must demonstrate electromagnetic compatibility, and electrical, mechanical, and thermal safety of any electrical components of the device. (6) Performance testing must validate reprocessing instructions for reusable components of the device. (7) Sterilization validation must be conducted for components that must be sterile. Performance testing must also demonstrate continued sterility and package integrity of components that must be sterile, as well as continued device functionality, over the identified shelf life of the device. (8) The patient-contacting components of the device must be demonstrated to be biocompatible. (9) Software verification, validation, and hazard analysis must be performed. (10) A human factors assessment must demonstrate that the device can be safely used by intended users. (11) Labeling must include: (i) A summary of standalone and clinical performance testing conducted with the device. The summary must describe performance measures, including sensitivity and specificity, and statistical confidence intervals, as well as performance of the device for all clinically relevant subgroups within the intended patient population; (ii) A description of the patient population that was used in development or training of the device algorithm; (iii) Information related to the limitations of device performance or subpopulations for which the device may not perform as expected or for whom the device has not been validated; (iv) Information needed to facilitate interpretation of all device outputs, and identification of the risks associated with misinterpretation of the device outputs; (v) A statement that the device is not intended for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis; (vi) User qualifications needed for safe use of the device, including a description of user training required prior to use, and a statement that the device is intended to be used by a physician trained in the clinical diagnosis and management of skin cancer ( e.g., (vii) Warnings to avoid unsafe exposure to any energy-emitting components of the device ( e.g., (viii) Instructions for device maintenance and validated methods and instructions for reprocessing of any reusable components. [91 FR 14457, Mar. 25, 2026] Subpart C [Reserved] Subpart D—Prosthetic Devices § 878.3250 External facial fracture fixation appliance. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000] § 878.3300 Surgical mesh. (a) Identification. (b) Classification. § 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material. (a) Identification. (b) Classification. § 878.3510 Carbon dioxide gas controlled tissue expander. (a) Identification. (b) Classification. (1) In-vivo performance testing must be conducted to obtain the adverse event profile associated with use, and demonstrate that the device performs as intended under anticipated conditions of use. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate the sterility of patient-contacting components of the device. (4) 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) Cycle testing of expander showing that there are no leaks or tears after repeated cycling; (ii) Mechanical assessment of implanted carbon dioxide (CO 2 (iii) Leak testing of expander showing that device does not leak CO 2 (iv) Assessment of gas permeability during expansion and after full expansion; and (v) Mechanical assessment of expander (tensile set, breaking force, shell joint test, and fused or adhered joint testing). (5) Performance data must be provided to demonstrate the electromagnetic compatibility, electrical safety, and wireless compatibility of the device. (6) Software verification, validation, and hazard analysis must be performed. (7) 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. (8) Human factors testing and analysis must validate that the device design and labeling are sufficient for the end user. (9) Physician labeling must include: (i) The operating parameters, name, and model number of the indicated external dosage controller; (ii) Information on how the device operates and the typical course of treatment; (iii) Information on the population for which the device has been demonstrated to be effective; (iv) A detailed summary of the device technical parameters; and (v) Provisions for choosing an appropriate size implant that would be exchanged for the tissue expander. (10) Patient labeling must include: (i) Warnings, precautions, and contraindications, and adverse events/complications; (ii) Information on how the device operates and the typical course of treatment; (iii) The probable risks and benefits associated with the use of the device; (iv) Post-operative care instructions; and (v) Alternative treatments. (11) Patient training must include instructions for device use, when it may be necessary to contact a physician, and cautionary measures to take when the device is implanted. [87 FR 6421, Feb. 4, 2022] § 878.3530 Silicone inflatable breast prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [53 FR 23872, June 24, 1988, as amended at 64 FR 45161, Aug. 19, 1999] § 878.3540 Silicone gel-filled breast prosthesis. (a) Identification Single-lumen silicone gel-filled breast prosthesis. (2) Double-lumen silicone gel-filled breast prosthesis. (3) Polyurethane covered silicone gel-filled breast prosthesis. (b) Classification. (c) Date premarket approval application (PMA) is required. [53 FR 23872, June 24, 1988, as amended at 56 FR 14627, Apr. 10, 1991] § 878.3550 Chin prosthesis. (a) Identification. (b) Classification. § 878.3590 Ear prosthesis. (a) Identification. (b) Classification. § 878.3610 Esophageal prosthesis. (a) Identification. (b) Classification. [65 FR 17145, Mar. 31, 2000] § 878.3680 Nose prosthesis. (a) Identification. (b) Classification. § 878.3720 Tracheal prosthesis. (a) Identification. (b) Classification. [65 FR 17146, Mar. 31, 2000] § 878.3750 External prosthesis adhesive. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001] § 878.3800 External aesthetic restoration prosthesis. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001; 90 FR 55986, Dec. 4, 2025] § 878.3900 Inflatable extremity splint. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001] § 878.3910 Noninflatable extremity splint. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000; 90 FR 55986, Dec. 4, 2025] § 878.3925 Plastic surgery kit and accessories. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000] Subpart E—Surgical Devices § 878.4010 Tissue adhesive. (a) Tissue adhesive for the topical approximation of skin Identification. (2) Classification. (b) Tissue adhesive for non-topical use Identification. (2) Classification. [73 FR 31033, May 30, 2008] § 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin. (a) Identification. (b) Classification. [75 FR 68794, Nov. 10, 2010] § 878.4014 Nonresorbable gauze/sponge for external use. (a) Identification. (b) Classification. [64 FR 53929, Oct. 5, 1999] § 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive. (a) Identification. (b) Classification. [74 FR 53167, Oct. 16, 2009] § 878.4018 Hydrophilic wound dressing. (a) Identification. (b) Classification. [64 FR 53929, Oct. 5, 1999] § 878.4020 Occlusive wound dressing. (a) Identification. (b) Classification. [64 FR 53929, Oct. 5, 1999] § 878.4022 Hydrogel wound dressing and burn dressing. (a) Identification. (b) Classification. [64 FR 53929, Oct. 5, 1999] § 878.4025 Silicone sheeting. (a) Identification. (b) Classification. [69 FR 48148, Aug. 9, 2004] § 878.4040 Surgical apparel. (a) Identification. (b) Classification. (i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. [53 FR 23872, June 24, 1988, as amended at 65 FR 2317, Jan. 14, 2000; 83 FR 22848, May 17, 2018] § 878.4100 Organ bag. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 65 FR 2318, Jan. 14, 2000] § 878.4160 Surgical camera and accessories. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 66 FR 38802, July 25, 2001] § 878.4165 Wound autofluorescence imaging device. (a) Identification. (b) Classification. [83 FR 52968, Oct. 19, 2018] § 878.4200 Introduction/drainage catheter and accessories. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000] § 878.4300 Implantable clip. (a) Identification. (b) Classification. § 878.4320 Removable skin clip. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000] § 878.4340 Contact cooling system for aesthetic use. (a) Identification. (b) Classification. [76 FR 6553, Feb. 7, 2011] § 878.4350 Cryosurgical unit and accessories. (a) Identification Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. (b) Classification. § 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia. (a) Identification. (b) Classification (1) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use. This information must include testing to demonstrate accuracy of the temperature control mechanism. (2) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of the device. (3) Software verification, validation, and hazard analysis must be performed. (4) The patient contacting components of the device must be demonstrated to be biocompatible. Material names must be provided. (5) Labeling must include the following: (i) A statement describing the potential risk of developing scalp metastasis. (ii) Information on the patient population and chemotherapeutic agents/regimen for which the device has been demonstrated to be effective. (iii) A summary of the non-clinical and/or clinical testing pertinent to use of the device. (iv) A summary of the device technical parameters, including temperature cooling range and duration of cooling. (v) A summary of the device- and procedure-related adverse events pertinent to use of the device. (vi) Information on how the device operates and the typical course of treatment. (6) Patient labeling must be provided and must include: (i) Relevant contraindications, warnings, precautions, and adverse effects/complications. (ii) Information on how the device operates and the typical course of treatment. (iii) Information on the patient population for which there is clinical evidence of effectiveness. (iv) The potential risks and benefits associated with use of the device. (v) Postoperative care instructions. (vi) A statement describing the potential risk of developing scalp metastasis. [81 FR 7453, Feb. 12, 2016] § 878.4370 Surgical drape and drape accessories. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019] § 878.4371 Irrigating wound retractor device. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible and evaluated for particulate matter. (2) Performance data must demonstrate the sterility and pyrogenicity of the patient-contacting components of the device. (3) Performance data must support shelf life by demonstrating continued functionality and sterility of the device over the identified shelf life. (4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must: (i) Characterize the tear resistance, tensile strength, and elongation properties of the barrier material; (ii) Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable; (iii) Characterize the forces required to deploy the device; (iv) Characterize the device's ranges of operation, including flow rates and maximum suction pressures; (v) Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound; and (vi) Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound. (5) The labeling must include or state the following information: (i) Device size or incision length range; (ii) Method of sterilization; (iii) Flammability classification; (iv) Non-pyrogenic; (v) Shelf life; and (vi) Maximum flow rate and suction pressure. [83 FR 24, Jan. 2, 2018] § 878.4380 Drape adhesive. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001] § 878.4400 Electrosurgical cutting and coagulation device and accessories. (a) Identification. (b) Classification. § 878.4410 Low energy ultrasound wound cleaner. (a) Identification. (b) Classification. [70 FR 67355, Nov. 7, 2005] § 878.4420 Electrosurgical device for over-the-counter aesthetic use. (a) Identification. (b) Classification. (1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters. (2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use. (3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use. (4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Instructions for cleaning the device must be validated. (7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device. (8) Software verification, validation, and hazard analysis must be performed. (9) Labeling must include: (i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users. (ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known. (iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events. [81 FR 42244, June 29, 2016] § 878.4425 Skin patch for treatment of hyperhidrosis. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and evaluate: (i) Reduction in hyperhidrosis using a validated measure; (ii) All adverse events; and (iii) Impact of residual chemical on the skin. (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) Thermal reactivity of the active device component(s); (ii) The total energy and energy flux (energy per unit area) of the device that is available to induce heating based on calorimetry; and (iii) Characterization of the distribution and homogeneity of the chemical(s) on and within the device. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance testing must support the shelf life of the device by demonstrating device functionality and package integrity over the labeled shelf life. (5) Patient and physician labeling must include: (i) A summary of the clinical performance testing conducted with the device; (ii) A listing of known risks including local adverse events, systemic effects, and adverse changes in perspiration; and (iii) Information about the known duration of effect. (6) Physician labeling must also include: (i) Instructions for safe disposal of the device; and (ii) A shelf life. [91 FR 39463, June 30, 2026] § 878.4430 Microneedling device for aesthetic use. (a) Identification. (b) Classification. (1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate. (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) Accuracy of needle penetration depth and puncture rate; (ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and (iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use. (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 intended shelf life. (5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device. (6) Software verification, validation, and hazard analysis must be performed for all software components of the device. (7) The patient-contacting components of the device must be demonstrated to be biocompatible. (8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device. (9) Labeling must include the following: (i) Information on how to operate the device and its components and the typical course of treatment; (ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate; (iii) Validated methods and instructions for reprocessing of any reusable components; (iv) Disposal instructions; and (v) A shelf life. (10) Patient labeling must be provided and must include: (i) Information on how the device operates and the typical course of treatment; (ii) The probable risks and benefits associated with use of the device; and (iii) Postoperative care instructions. [83 FR 26577, June 8, 2018] § 878.4440 Eye pad. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 878.4450 Nonabsorbable gauze for internal use. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] § 878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use. (a) Identification. (b) Classification. (1) Performance data must demonstrate the biocompatibility of patient-contacting components. (2) Performance data must demonstrate the sterility of patient-contacting components including endotoxin and pyrogenicity assessments. (3) Performance data must support device stability by demonstrating continued sterility of the patient-contacting components of the device, package integrity, and device functionality over the requested shelf life. (4) Assessment of material characteristics must be sufficient to support safety under anticipated conditions of use. Assessments must include the following: (i) Material specifications. (ii) Immunogenicity. (iii) Viral inactivation for animal-derived materials. (5) 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) Absorption capacity. (ii) Extent of swelling. (iii) Mechanical properties. (iv) Expansion force/pressure. (v) Radiopacity. (vi) Deployment/applicator functionality. (6) In vivo performance data must demonstrate safe and effective use by verifying that the device performs as intended under anticipated conditions of use. Appropriate analysis/testing must demonstrate that the product: Controls bleeding, does not promote adverse local or systemic effects, and can be completely removed from the wound. The following performance characteristics must be tested: (i) Deployment. (ii) Control of bleeding. (iii) Radiopacity. (iv) Retrieval. (v) Assessment of local and systemic effects. (7) Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by emergency responders deploying the device as well as surgeons retrieving the device from wounds. (8) Labeling must include: (i) Specific instructions for deployment by emergency responders and retrieval by surgeons. (ii) Warnings, cautions, and limitations needed for safe use of the device. (iii) Information on how the device operates and the typical course of treatment. (iv) A detailed summary of the in vivo and human factors testing pertinent to use of the device. (v) Appropriate imaging information to ensure complete retrieval of device. (vi) An expiration date/shelf life. [79 FR 34224, June 16, 2014] § 878.4454 Non-absorbable, hemostatic gauze for temporary internal use. (a) Identification. (b) Classification. (1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must: (i) Demonstrate that the device is able to achieve hemostasis; (ii) Demonstrate that the device can be radiographically detected; and (iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation. (2) The device must be demonstrated to be biocompatible. (3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed: (i) In vitro clot assessment; (ii) Particulate release testing; (iii) Physical characterization, including swelling percent and particulate size; (iv) Chemical characterization; (v) Radiopacity testing; and (vi) Mechanical integrity testing, including tensile strength and tear strength. (4) Performance data must demonstrate the sterility of the device. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Labeling must include the following: (i) Instructions for use, including an instruction to remove all visible device components by irrigation; (ii) The maximum amount of time the device may be left within the body; (iii) A shelf life; (iv) A contraindication for intravascular use of the device; and (v) A warning regarding the potential for adhesion formation. [83 FR 6794, Feb. 15, 2018] § 878.4456 Hemostatic device for intraluminal gastrointestinal use. (a) Identification. (b) Classification. (1) The device must be demonstrated to be biocompatible. (2) Performance data must support the sterility and pyrogenicity 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 identified shelf life. (4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following: (i) The ability to deliver the hemostatic material to the bleeding site; (ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and (iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation. (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids. (ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems. (6) Labeling must include: (i) Information identifying and explaining how to use the device and its components; and (ii) A shelf life. [83 FR 52971, Oct. 19, 2018] § 878.4460 Non-powdered surgeon's glove. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 66 FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016] § 878.4470 Surgeon's gloving cream. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 878.4490 Absorbable hemostatic agent and dressing. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. § 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture. (a) Identification. (b) Classification. [56 FR 47151, Sept. 18, 1991, as amended at 68 FR 32984, June 3, 2003] § 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology. (a) Identification. (b) Classification. [72 FR 43146, Aug. 3, 2007] § 878.4495 Stainless steel suture. (a) Identification. (b) Classification. [65 FR 19836, Apr. 13, 2000, as amended at 68 FR 32984, June 3, 2003; 84 FR 71814, Dec. 30, 2019] § 878.4520 Polytetrafluoroethylene injectable. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. § 878.4550 Autofluorescence detection device for general surgery and dermatological use. (a) Identification. (b) Classification. (1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) Performance testing must demonstrate the sterility of patient-contacting components of the device. (6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin. (8) Labeling must include the following: (i) Instructions for use; (ii) The detection performance characteristics of the device when used as intended; and (iii) A shelf life for any sterile components. [87 FR 24273, Apr. 25, 2022] § 878.4580 Surgical lamp. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019] § 878.4590 Focused ultrasound stimulator system for aesthetic use. (a) Identification. (b) Classification. [76 FR 43121, July 20, 2011] § 878.4630 Ultraviolet lamp for dermatologic disorders. (a) Identification. (b) Classification. § 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products. (a) Identification. (b) Classification. (1) Conduct performance testing that demonstrates the following: (i) Device meets appropriate output performance specifications such as wavelengths, energy density, and lamp life; and (ii) Device's safety features, such as timers to limit UV exposure and alarms, function properly. (2) Demonstrate that device is mechanically safe to prevent user injury. (3) Demonstrate software verification, validation, and hazard analysis. (4) Demonstrate that device is biocompatible. (5) Demonstrate that device is electrically safe and electromagnetically compatible in its intended use environment. (6) Labeling Sunlamp products. Attention: This sunlamp product should not be used on persons under the age of 18 years. (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions. (ii) Sunlamp products and UV lamps intended for use in sunlamp products. (A) “Contraindication: This product is contraindicated for use on persons under the age of 18 years.” (B) “Contraindication: This product must not be used if skin lesions or open wounds are present.” (C) “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.” (D) “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.” (c) Performance standard. [79 FR 31213, June 2, 2014] § 878.4660 Skin marker. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 878.4670 Internal tissue marker. (a) Identification. (b) Classification. (1) The device must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided. (2) Performance testing must demonstrate that the device performs as intended to mark the tissue for which it is indicated. (3) Performance data must demonstrate the sterility of the device. (4) Performance data must support the shelf life of the device by demonstrating sterility, package integrity, device functionality, and material stability over the requested shelf life. (5) Labeling must include: (i) A warning that the device must not be used on a non-sterile surface prior to use internally. (ii) An expiration date/shelf life. (iii) Single use only labeling must be labeled directly on the device. [80 FR 46486, Aug. 5, 2015] § 878.4675 Breast implant suction retrieval system. (a) Identification. (b) Classification. (1) Animal performance testing must demonstrate that the device performs as intended and will not result in tissue injury. Testing must: (i) Demonstrate the ability to remove implants of the sizes and types specified in device labeling; and (ii) Assess tissue integrity and injury at multiple time intervals to assess tissue healing response after device use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Characterization of the range of device operation, including minimum and maximum vacuum suction parameters; (ii) Durability and integrity testing; and (iii) Characterization of control and variation of suction application. (3) Performance testing must demonstrate the sterility of the device. (4) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (5) The tissue-contacting components of the device must be demonstrated to be biocompatible. (6) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the directions for use. (7) Labeling must include the following: (i) Summary of device specifications, including vacuum suction pressure ranges and bottle capacity; and (ii) Sizes and types of implants that can be removed with the device. [91 FR 38503, June 26, 2026] § 878.4680 Nonpowered, single patient, portable suction apparatus. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000] § 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy. (a) Identification. (b) Classification. [75 FR 70114, Nov. 17, 2010] § 878.4685 Extracorporeal shock wave device for treatment of chronic wounds. (a) Identification. (b) Classification. (1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use. (4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device. (5) Software verification, validation, and hazard analysis must be performed. (6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life. (7) Physician labeling must include: (i) Information on how the device operates and the typical course of treatment; (ii) A detailed summary of the device's technical parameters; (iii) Validated methods and instructions for reprocessing of any reusable components; and (iv) Instructions for preventing hearing loss by use of hearing protection. (8) Patient labeling must include: (i) Relevant contraindications, warnings, precautions, adverse effects, and complications; (ii) Information on how the device operates and the typical course of treatment; (iii) The probable risks and benefits associated with the use of the device; (iv) Post-procedure care instructions; and (v) Alternative treatments. [83 FR 9699, Mar. 7, 2018] § 878.4700 Surgical microscope and accessories. (a) Identification. (b) Classification. [55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 878.4730 Surgical skin degreaser or adhesive tape solvent. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 878.4740 Surgical stapler. (a) Surgical stapler for external use. (1) Identification. (2) Classification. (b) Surgical stapler for internal use. (1) Identification. (2) Classification. (i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following: (A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type; (B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force; (C) Measurement of staple line strength; (D) Confirmation of staple line integrity; and (E) In vivo confirmation of staple line hemostasis. (ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device. (iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed. (iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use. (v) The elements of the device that may contact the patient must be demonstrated to be biocompatible. (vi) Performance data must demonstrate the sterility of the device. (vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling. (viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life. (ix) Labeling of the device must include the following: (A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity. (B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 (C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling. (D) List of staples with which the stapler has been demonstrated to be compatible. (E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device. (F) Information regarding tissues on which the stapler is intended to be used. (G) Identification of safety mechanisms of the stapler. (H) Validated methods and instructions for reprocessing of any reusable device components. (I) An expiration date/shelf life. (x) Package labels must include critical information and technical characteristics necessary for proper device selection. [86 FR 16204, Oct. 8, 2021] § 878.4750 Implantable staple. (a) Identification. (b) Classification. § 878.4755 Absorbable lung biopsy plug. (a) Identification. (b) Classification. (1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use. (2) Performance testing must demonstrate deployment as indicated in the accompanying labeling, including the indicated introducer needles, and demonstrate expansion and resorption characteristics in a clinically relevant environment. (3) In vivo evaluation must demonstrate performance characteristics of the device, including the ability of the plug to not prematurely resorb or migrate and the rate of pneumothorax. (4) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the plug. (5) Shelf-life testing must demonstrate the shelf-life of the device including the physical characteristics of the plug. (6) The device must be demonstrated to be biocompatible. (7) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device and appropriate warnings. Labeling must include identification of compatible introducer needles. [79 FR 13219, Mar. 10, 2014] § 878.4760 Removable skin staple. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000] § 878.4780 Powered suction pump. (a) Identification. (b) Classification. § 878.4783 Negative pressure wound therapy device for reduction of wound complications. (a) Identification. (b) Classification. (1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following: (i) Wound complication rates; and (ii) 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) 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) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the instructions for use. (6) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested in a worst-case scenario for the intended use life: (i) Ability to maintain pressure levels at the wound site under a worst-case scenario for the intended use life; (ii) Fluid removal rate consistent with the wound types specified in the indications for use; and (iii) Timely triggering of all alarms. (7) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device. (8) Software verification, validation, and hazard analysis must be performed. (9) Labeling must include the following: (i) Instructions for use; (ii) A summary of the device technical specifications, including pressure settings, modes ( e.g., (iii) Compatible components and devices; (iv) A summary of the clinical evidence for the indications for use; (v) A shelf life for sterile components; and (vi) Use life and intended use environments. (10) For devices intended for use outside of a healthcare facility, patient labeling must include the following: (i) Information on how to operate the device and its components and the typical course of treatment; (ii) Information on when to contact a healthcare professional; and (iii) Use life. [86 FR 70734, Dec. 10, 2021] § 878.4790 Powered surgical instrument for improvement in the appearance of cellulite. (a) Identification. (b) Classification. (1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device. (2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites. (3) All elements of the device that may contact the patient must be demonstrated to be biocompatible. (4) Electrical safety and electromagnetic compatibility of the device must be demonstrated. (5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications. (6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components. [79 FR 31861, June 3, 2014] § 878.4800 Manual surgical instrument for general use. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001; 86 FR 56204, Oct. 8, 2021; 86 FR 66188, Nov. 22, 2021] § 878.4805 Manual percutaneous surgical set assembled in the abdomen. (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 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 performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Dimensional verification testing must be conducted. (ii) Force verification testing must be conducted. The force testing must demonstrate the forces necessary to insert and operate each component of the device during use as intended. (iii) Functional verification testing of the device components must be conducted. (5) Simulated use testing in an anatomically relevant animal model must demonstrate the device's ability to penetrate soft tissue, be assembled in situ, and to grasp, hold and manipulate soft tissues in the intended treatment area. (6) The labeling must include the following: (i) Instructions for use, including detailed instructions for instrument assembly, disassembly, and removal; and (ii) A shelf life. [86 FR 71569, Dec. 17, 2021] § 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology. (a) Identification. (2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon. (b) Classification. (2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. 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 § 878.9. [53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] § 878.4815 Magnetic surgical instrument system. (a) Identification. (b) Classification. (1) In vivo performance data must demonstrate that the device performs as intended under anticipated conditions of use. Testing must demonstrate the ability of the device to grasp, hold, retract, mobilize, or manipulate soft tissue and organs. (2) Non-clinical performance data must demonstrate that the system performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Magnetic field strength testing characterization to identify the distances from the magnet that are safe for patients and users with ferromagnetic implants, devices, or objects. (ii) Ability of the internal surgical instrument(s) to be coupled, de-coupled, and re-coupled with the external magnet over the external magnet use life. (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 that are patient-contacting. (5) Methods and instructions for reprocessing reusable components must be validated. (6) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components and device functionality over the labeled shelf life. (7) Training must be developed and validated by human factors testing and analysis to ensure users can follow the instructions for use to allow safe use of the device. (8) Labeling must include: (i) Magnetic field safe zones. (ii) Instructions for proper device use. (iii) A screening checklist to ensure that all patients and operating staff are screened from bringing ferromagnetic implants, devices, or objects near the external magnet. (iv) Reprocessing instructions for any reusable components. (v) Shelf life. (vi) Use life. [81 FR 64763, Sept. 21, 2016] § 878.4820 Surgical instrument motors and accessories/attachments. (a) Identification. (b) Classification. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, 2000] § 878.4825 General laparoscopic power morcellation containment system. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing 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 intended shelf life. (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) Demonstration of the device impermeability to tissue, cells, and fluids; (ii) Demonstration that the device allows for the insertion/withdrawal of laparoscopic instruments while maintaining pneumoperitoneum; (iii) Demonstration that the containment system provides adequate space to perform morcellation and adequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera; (iv) Demonstration that compatible laparoscopic instruments and morcellators do not compromise the integrity of the containment system; and (v) Demonstration that users can adequately deploy the device, morcellate a specimen without compromising the integrity of the device, and remove the device without spillage of contents. (5) Training must be developed and validated to ensure users can follow the instructions for use. (6) Labeling must include: (i) A contraindication for use in gynecological procedures; (ii) A contraindication against use of tissue that is known or suspected to contain malignancy; (iii) The following boxed warning: “Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. The use of laparoscopic power morcellators may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk;” (iv) A statement limiting use of device to physicians who have completed the training program; and (v) A shelf life. [86 FR 66458, Nov. 23, 2021] § 878.4830 Absorbable surgical gut suture. (a) Identification. (b) Classification. [54 FR 50738, Dec. 11, 1989, as amended at 68 FR 32984, June 3, 2003] § 878.4840 Absorbable polydioxanone surgical suture. (a) Identification. (b) Classification. [67 FR 77676, Dec. 19, 2002] § 878.4850 Blood lancets. (a) Single use only blood lancet with an integral sharps injury prevention feature Identification. (2) Classification. (i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( e.g., (v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( e.g., (D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( 1 ( 2 (vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (b) Single use only blood lancet without an integral sharps injury prevention feature Identification. (2) Classification. (i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( e.g., (v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( e.g., (D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( 1 ( 2 (vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (c) Multiple use blood lancet for single patient use only Identification. (2) Classification. (i) The design characteristics of the device must ensure that: (A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and (B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( e.g., (v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected. (vi) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use. (C) Handwashing instructions for the user before and after use of the device. (D) Instructions on preparation ( e.g., (E) Instructions on the cleaning and disinfection of the device. (F) Instructions for the safe disposal of the device. (G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades. (H) Labeling must be appropriate for the intended use environment. ( 1 ( 2 (vii) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.” (B) “Used lancet blades must be safely discarded after a single use.” (C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.” (d) Multiple use blood lancet for multiple patient use Identification. (2) Classification. (3) Date PMA or notice of completion of a PDP is required: [86 FR 66188, Nov. 22, 2021, as amended at 86 FR 66179, Nov. 22, 2021] § 878.4860 Light based energy source device for topical application. (a) Identification. (b) Classification. (1) The technical parameters of the device, including wavelength, treatment time, treatment area, energy density, spot size, and power, must be characterized. (2) The cleaning and disinfection instructions for the device must be validated. (3) The device must be demonstrated to be biocompatible. (4) Performance testing must validate electromagnetic compatibility (EMC), ocular safety, and electrical safety of the device. (5) Labeling must direct end-users to contact the device manufacturer and MedWatch if they experience any adverse events when using this device. (6) Labeling must include specific information pertinent to use of the device by the intended patient population and the treatment regimen. (7) Simulated use testing must include information from a usability, label comprehension and self-selection study to demonstrate that the device can be used by the intended patient population without any assistance. (8) Clinical data must show adequate reduction in time to healing and assess risks of redness, discomfort, burns, and blisters. [83 FR 52969, Oct. 19, 2018] § 878.4880 Phototherapy device for reducing the appearance of acute post-surgical incisions. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include the following: (i) Verification and validation testing of the spectrum and power intensity of the light source; (ii) Heat dissipation from the area following device application; and (iii) Biophotonic properties of the photoconverter gel, including radiant fluence (transmitted light and fluorescence) delivered through the photoconverter gel by the device. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must evaluate the sterility of the patient-contacting components of the device. (4) Performance data must support the shelf life of the photoconverter gel by demonstrating continued sterility and functional performance over the identified shelf life. (5) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device in the intended use environment. (6) Software verification, validation, and hazard analysis must be performed for any software components. (7) Labeling must include the following: (i) A summary of the device technical specifications, including light wavelength, irradiance, and application area; (ii) Warnings for ensuring eye safety, including use of protective eyeglasses used for both the operator and the patient; and (iii) A shelf life for the photoconverter gel. [91 FR 23359, May 1, 2026] § 878.4930 Suture retention device. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 878.4950 Manual operating table and accessories and manual operating chair and accessories. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 878.4960 Operating tables and accessories and operating chairs and accessories. (a) Identification. (b) Classification. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, Jan. 14, 2000] § 878.4961 Mountable electromechanical surgical system for transluminal approaches. (a) Identification. (b) Classification. (1) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. (2) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (3) The device manufacturer must conduct and complete post-market surveillance, including an impact of the training program on user learning, behavior, and performance, in accordance with an FDA-agreed-upon protocol. The device manufacturer must submit post-market surveillance reports that contain current data and findings in accordance with the FDA-agreed-upon protocol. (4) The device manufacturer must submit a report to FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling or device-specific use training program, which did not require submission of a premarket notification during the reporting period. (5) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness of the device has not been evaluated for outcomes related to the treatment or prevention of cancer, including but not limited to risk reduction, overall survival, disease-free survival and local recurrence, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A detailed summary of the post-market surveillance data collected under paragraph (b)(3) of this section and any necessary modifications to the labeling to accurately reflect outcomes based upon the post-market surveillance data collected under paragraph (b)(3) of this section. (6) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. (7) Human factors validation testing must be performed and must demonstrate that the user interfaces of the system support safe use in an operating room environment. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and precision; (ii) System testing; (iii) Instrument reliability; (iv) Thermal effects on tissue; (v) Human-device interface; (vi) Mounting hardware testing; (vii) Workspace access testing; and (viii) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. Software documentation must include an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. [87 FR 26995, May 6, 2022] § 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture. (a) Identification. (b) Classification. [56 FR 24685, May 31, 1991, as amended at 68 FR 32984, June 3, 2003] § 878.5010 Nonabsorbable polypropylene surgical suture. (a) Identification. (b) Classification. [56 FR 24685, May 31, 1991, as amended at 68 FR 32984, June 3, 2003] § 878.5020 Nonabsorbable polyamide surgical suture. (a) Identification. (b) Classification. [56 FR 24685, May 31, 1991, as amended at 68 FR 32985, June 3, 2003] § 878.5030 Natural nonabsorbable silk surgical suture. (a) Identification. Bombyx mori B. mori Bombycidae. (b) Classification. [58 FR 57558, Oct. 26, 1993, as amended at 68 FR 32985, June 3, 2003] § 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture. (a) Identification. (b) Classification. [65 FR 20735, Apr. 18, 2000, as amended at 68 FR 32985, June 3, 2003] § 878.5040 Suction lipoplasty system. (a) Identification. 1/3 (b) Classification. [63 FR 7705, Feb. 17, 1998] § 878.5050 Surgical smoke precipitator. (a) Identification. (b) Classification. (1) Adverse tissue reaction must be mitigated through the following: (i) Chemical characterization and toxicological risk assessment of the treated surgical smoke. (ii) Demonstration that the elements of the device that may contact the patient are biocompatible. (2) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended. (3) Software verification, validation, and hazard analysis must be performed. (4) Performance data must demonstrate the sterility of the patient contacting components of the device. (5) Performance data must support the shelf life of the sterile components of the device by demonstrating continued functionality, sterility, and package integrity over the identified shelf life. (6) Animal simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Device must be demonstrated to be effectively inserted, positioned, and removed from the site of use. (ii) Device must be demonstrated to precipitate surgical smoke particulates to clear the visual field for laparoscopic surgeries. (iii) Device must be demonstrated to be non-damaging to the site of use and animal subject. (7) Labeling must identify the following: (i) Detailed instructions for use. (ii) Electrical safety and electromagnetic compatibility information. (iii) A shelf life. [83 FR 4143, Jan. 30, 2018] Subpart F—Therapeutic Devices § 878.5070 Air-handling apparatus for a surgical operating room. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019] § 878.5080 Air-handling apparatus accessory. (a) Identification. (b) Classification. [84 FR 14870, Apr. 12, 2019] § 878.5350 Needle-type epilator. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] § 878.5360 Tweezer-type epilator. (a) Identification. (b) Classification. [63 FR 57060, Oct. 26, 1998] § 878.5400 Low level laser system for aesthetic use (a) Identification. (b) Classification. [76 FR 20842, Apr. 14, 2011] § 878.5650 Topical oxygen chamber for extremities. (a) Identification. (b) Classification. [76 FR 22807, Apr. 25, 2011] § 878.5900 Nonpneumatic tourniquet. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 878.5910 Pneumatic tourniquet. (a) Identification. (b) Classification. [53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]