PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted. Editorial Note: Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 880.1 Scope. (a) This part sets forth the classification of general hospital and personal use 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 general hospital and personal use 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 17738, May 11, 1987, as amended at 69 FR 71704, Dec. 8, 2004; 78 FR 18233, Mar. 26, 2013] § 880.3 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” devices 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 17738, May 11, 1987] § 880.9 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 2318, Jan. 14, 2000] Subpart B [Reserved] Subpart C—General Hospital and Personal Use Monitoring Devices § 880.2200 Liquid crystal forehead temperature strip. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59228, Nov. 3, 1998] § 880.2400 Bed-patient monitor. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 880.2420 Electronic monitor for gravity flow infusion systems. (a) Identification. (b) Classification. § 880.2460 Electrically powered spinal fluid pressure monitor. (a) Identification. (b) Classification. § 880.2500 Spinal fluid manometer. (a) Identification. (b) Classification. § 880.2700 Stand-on patient scale. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38803, July 25, 2001; 90 FR 55986, Dec. 4, 2025] § 880.2720 Patient scale. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] § 880.2740 Surgical sponge scale. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001; 90 FR 55986, Dec. 4, 2025] § 880.2750 Image processing device for estimation of external blood loss. (a) Identification. (b) Classification. (1) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Demonstration of the performance characteristics must include a comparison to a scientifically valid alternative method for measuring deposited hemoglobin mass. The following use conditions must be tested: (i) Lighting conditions; (ii) Range of expected hemoglobin concentrations; (iii) Range of expected blood volume absorption; and (iv) Presence of other non-sanguineous fluids ( e.g., (2) Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by intended users of the device. (3) Appropriate analysis and non-clinical testing must validate the electromagnetic compatibility (EMC) and wireless performance of the device. (4) Appropriate software verification, validation, and hazard analysis must be performed. (5) Software display must include an estimate of the cumulative error associated with estimated blood loss values. (6) Labeling must include: (i) Warnings, cautions, and limitations needed for safe use of the device; (ii) A detailed summary of the performance testing pertinent to use of the device, including a description of the bias and variance the device exhibited during testing; (iii) The validated surgical materials, range of hemoglobin mass, software, hardware, and accessories that the device is intended to be used with; and (iv) EMC and wireless technology instructions and information. [82 FR 60307, Dec. 20, 2017] § 880.2800 Sterilization process indicator. (a) Biological sterilization process indicator Identification. (2) Classification. (b) Physical/chemical sterilization process indicator Identification. (2) Classification. § 880.2900 Clinical color change thermometer. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38804, July 25, 2001] § 880.2910 Clinical electronic thermometer. (a) Identification. (b) Classification. (1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device. [45 FR 69682, Oct. 21, 1980, as amended at 90 FR 25891, June 18, 2025] § 880.2920 Clinical mercury thermometer. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59228, Nov. 3, 1998] § 880.2930 Apgar timer. (a) Identification. (b) Classification. [63 FR 59718, Nov. 5, 1998, as amended at 90 FR 55986, Dec. 4, 2025] Subparts D-E [Reserved] Subpart F—General Hospital and Personal Use Therapeutic Devices § 880.5025 I.V. container. (a) Identification. (b) Classification. § 880.5045 Medical recirculating air cleaner. (a) Identification. (b) Classification. § 880.5075 Elastic bandage. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001; 90 FR 55986, Dec. 4, 2025] § 880.5090 Liquid bandage. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000] § 880.5100 AC-powered adjustable hospital bed. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998] § 880.5110 Hydraulic adjustable hospital bed. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001] § 880.5120 Manual adjustable hospital bed. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38804, July 25, 2001; 90 FR 55986, Dec. 4, 2025] § 880.5130 Infant radiant warmer. (a) Identification. (b) Classification. (1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer; (2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and (3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device. [62 FR 33350, June 19, 1997] § 880.5140 Pediatric medical crib. (a) Identification. (b) Classification. (1) Crib design and performance testing shall demonstrate the mechanical and structural stability of the crib under expected conditions of use, including the security of latches and other locking mechanisms when engaged; (2) Materials used shall be appropriate for the conditions of use, allow for proper sanitation, and be free from surface defects that could result in injuries; (3) The height of the rail and end panel as measured from the top of the rail or panel in its highest position to the top of the mattress support in its lowest position shall be at least 26 inches (66 centimeters). Any mattress used in this crib must not exceed a thickness of 6 inches; (4) Hardware and fasteners shall be designed and constructed to eliminate mechanical hazards to the patient; (5) The distance between components of the side rail ( i.e., 3/8 (6) The mattress must fit tightly around all four sides of the crib base, such that entrapment or impingement of occupant is prevented; (7) The mattress for the crib shall meet the Consumer Product Safety Commission (CPSC) Standard for the flammability of mattresses and mattress pads (FF 4-72, amended) and Standard for the flammability (open flame) of mattress sets, 16 CFR parts 1632 and 1633, respectively; and (8) Each device must have the following label(s) affixed: (i) Adequate instructions for users to care for, maintain, and clean the crib; and (ii) A warning label on at least two sides of the medical crib with the following language in text of at least 9 millimeters in height: WARNING: Never leave a child unsupervised when the moveable side is open or not secured. [81 FR 91737, Dec. 19, 2016] § 880.5145 Medical bassinet. (a) Identification. (b) Classification. (1) The manufacturer must conduct performance testing to determine material compatibility with cleansing products labeled to clean the device. Testing must demonstrate that the cleaning instructions provided by the manufacturer do not cause crazing, cracking, or deterioration of the device; (2) Manufacturers shall conduct performance testing to ensure the mechanical and structural stability of the bassinet under expected conditions of use, including transport of patients in the bassinet. Testing must demonstrate that failures such as wheel or caster breakage do not occur and that the device does not present a tipping hazard due to any mechanical failures under expected conditions of use; and (3) Each device must have the following label(s) affixed: (i) Adequate instructions for users to care for, maintain, and clean the bassinet; and (ii) A warning label on at least two sides of the plastic basket or bed component with the following language in text of at least 9 millimeters in height: WARNING: To avoid tipping hazards of this device, make sure that the basket or bed component sits firmly in the base and that all doors, drawers, and casters are secure. [81 FR 91737, Dec. 19, 2016] § 880.5150 Nonpowered flotation therapy mattress. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001; 90 FR 55986, Dec. 4, 2025] § 880.5160 Therapeutic medical binder. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001; 90 FR 55986, Dec. 4, 2025] § 880.5180 Burn sheet. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, 2001] § 880.5200 Intravascular catheter. (a) Identification. (b) Classification. § 880.5210 Intravascular catheter securement device. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, 2001] § 880.5220 Intravenous catheter force-activated separation device. (a) Identification. (b) Classification. (1) Performance data must be provided to demonstrate clinically acceptable performance for the intended use of the device. (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) Separation force testing; (ii) Validation of anti-reconnect features; (iii) Air and liquid leakage testing, both before and after separation; (iv) Luer connection testing; (v) Flow rate testing; (vi) Particulate testing; and (vii) Microbial ingress testing. (3) The device must be demonstrated to be biocompatible. (4) Performance testing must demonstrate that the device is sterile and non-pyrogenic. (5) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life. (6) Device labeling must include: (i) Instructions for use; and (ii) A discussion of catheter dressings intended to be used with the device. [89 FR 66560, Aug. 16, 2024] § 880.5240 Medical adhesive tape and adhesive bandage. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, 2001] § 880.5270 Neonatal eye pad. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000; 90 FR 55986, Dec. 4, 2025] § 880.5300 Medical absorbent fiber. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001; 90 FR 55986, Dec. 4, 2025] § 880.5400 Neonatal incubator. (a) Identification. (b) Classification. § 880.5405 Active noise attenuation system for infant incubators. (a) Identification. (b) Classification. (1) Non-clinical performance testing under anticipated conditions of use must demonstrate that the device performs as intended, including: (i) Verification and validation of critical acoustic parameters, including the maximum output of the device; (ii) Verification and validation of the attenuation performance of the device, including: (A) Testing with compatible incubator model(s) and dimensions; (B) Attenuation performance testing simulating different infant locations and orientations within the incubator; and (C) Testing with relevant noise sources and room configurations. (2) Software validation, verification, and hazard analysis must be performed. (3) Electrical safety and electromagnetic compatibility testing must be performed for any electrical components of the device. (4) The patient- or user-contacting components of the device must be demonstrated to be biocompatible. (5) Labeling for the device must include: (i) Instructions for infant placement and the expected attenuation performance of the device; (ii) Warnings regarding the risks of exposure to the potential maximum output of the device; (iii) Methods and instructions for cleaning and disinfection; and (iv) Identification of the incubator(s) that the device is intended to be used with. [91 FR 46836, July 27, 2026] § 880.5410 Neonatal transport incubator. (a) Identification. (b) Classification. § 880.5420 Pressure infusor for an I.V. bag. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000] § 880.5430 Nonelectrically powered fluid injector. (a) Identification. (b) Classification. § 880.5440 Intravascular administration set. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 15798, Mar. 21, 2001] § 880.5445 Intravascular administration set, automated air removal system. (a) Identification. (b) Classification. (1) Provide an argument demonstrating that all reasonably foreseeable hazards have been adequately addressed with respect to the persons for whose use the device is represented or intended and the conditions of use for the device, which includes the following: (i) Description of the device indications for use, design, and technology, use environments, and users in sufficient detail to determine that the device complies with all special controls. (ii) Demonstrate that controls are implemented to address device system hazards and their causes. (iii) Include a justification supporting the acceptability criteria for each hazard control. (iv) A traceability analysis demonstrating that all credible hazards have at least one corresponding control and that all controls have been verified and validated in the final device design. (2) Appropriate software verification, validation, and hazard analysis must be performed. (3) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of fluid path contacting components and the shelf life of these components. (5) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC). (6) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Device system and component reliability testing must be conducted. (ii) Fluid ingress protection testing must be conducted. (iii) Testing of safety controls must be performed to demonstrate adequate mitigation of hazardous situations, including sensor failure, flow control failure, improper device position, device malfunction, infusion delivery error, and release of air to the patient. (7) A human factors validation study must demonstrate that use hazards are adequately addressed. (8) The labeling must include the following: (i) The device's air identification and removal response time. (ii) The device's minimum air volume identification sensitivity. (iii) The minimum and maximum flow rates at which the device is capable of reliably detecting and removing air. (iv) Quantification of any fluid loss during device air removal operations as a function of flow rate. [79 FR 28406, May 16, 2014] § 880.5450 Patient care reverse isolation chamber. (a) Identification. (b) Classification. § 880.5475 Jet lavage. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998] § 880.5500 AC-powered patient lift. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998] § 880.5510 Non-AC-powered patient lift. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38804, July 25, 2001] § 880.5550 Alternating pressure air flotation mattress. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998] § 880.5560 Temperature regulated water mattress. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38804, July 25, 2001] § 880.5570 Hypodermic single lumen needle. (a) Identification. (b) Classification. § 880.5580 Acupuncture needle. (a) Identification. (b) Classification. (1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109, (2) Device material biocompatibility, and (3) Device sterility. [61 FR 64617, Dec. 6, 1996, as amended at 84 FR 71815, Dec. 30, 2019] § 880.5630 Nipple shield. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 33804, July 25, 2001] § 880.5640 Lamb feeding nipple. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001; 90 FR 55987, Dec. 4, 2025] § 880.5680 Pediatric position holder. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001; 84 FR 71815, Dec. 30, 2019; 90 FR 55987, Dec. 4, 2025] § 880.5690 Infant supine sleep system. (a) Identification. (b) Classification. (1) Premarket clinical information and, as determined by FDA, postmarket surveillance data acquired under anticipated conditions of use must be collected to fulfill the following: (i) Demonstrate that the device holds the infant on the back; (ii) Provide data on adverse events (including deaths and injuries) and malfunctions to demonstrate the device can be safely used in the intended use population; and (iii) Provide data to demonstrate that use of the device does not increase the rate of SIDS/SUID in the intended use population. (2) Human factors testing must demonstrate that the user can safely and correctly use the device. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted: (i) Testing to ensure the mechanical and structural stability of the device and demonstrate that the device does not present a tipping hazard due to mechanical failures; and (ii) Material compatibility testing to demonstrate that the cleaning instructions provided by the manufacturer do not cause crazing, cracking, or deterioration of the device. (5) Labeling must include: (i) Unless clinical performance data demonstrates that it can be removed or modified, a prominent warning that the device has not been demonstrated to reduce the risk of SIDS/SUID. Such warning must appear prominently on all labeling; (ii) A summary of available clinical information with the device, including a discussion of adverse events; (iii) A warning that the device is only indicated for use with infants who cannot consistently roll over; (iv) Instructions to ensure proper fit; (v) Instructions for cleaning the device; and (vi) Information regarding safe sleep practices to ensure the safe use of the device, including: (A) Recommendations for safe sleep environments; and (B) The level of supervision necessary to monitor a sleeping infant. [91 FR 38508, June 26, 2026] § 880.5700 Neonatal phototherapy unit. (a) Identification. (b) Classification. § 880.5725 Infusion pump. (a) Identification. (b) Classification. § 880.5730 Alternate controller enabled infusion pump. (a) Identification. (b) Classification. (1) Design verification and validation must include the following: (i) Evidence demonstrating that device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions. (A) Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes ( e.g., (B) Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices. (ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration ( e.g., (iii) Validation testing results demonstrating compatibility with drugs that may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions that may affect drug stability ( e.g., (iv) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low. (v) Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance. (vi) The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment. (vii) For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated. (viii) For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing. (2) Design verification and validation activities must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following: (i) Risk control measures shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented. (ii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design. (3) The device shall include validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following: (i) Secure authentication (pairing) to external devices. (ii) Secure, accurate, and reliable means of data transmission between the pump and connected devices. (iii) Sharing of necessary state information between the pump and any digitally connected alternate controllers ( e.g., (iv) Ensuring that the pump continues to operate safely when data is received in a manner outside the bounds of the parameters specified. (v) A detailed process and procedure for sharing the pump interface specification with digitally connected devices and for validating the correct implementation of that protocol. (4) The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or re-established after an interruption ( e.g., e.g., (5) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the system must, at a minimum, include: (i) A record of all drug delivery (ii) Commands issued to the pump and pump confirmations (iii) Device malfunctions (iv) Alarms and alerts and associated acknowledgements (v) Connectivity events ( e.g., (6) Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use. (7) Device labeling must include the following: (i) A prominent statement identifying the drugs that are compatible with the device, including the identity and concentration of those drugs as appropriate. (ii) A description of the minimum and maximum basal rates, minimum and maximum bolus volumes, and the increment size for basal and bolus delivery, or other similarly applicable information about drug delivery parameters. (iii) A description of the pump accuracy at minimum, intermediate, and maximum bolus delivery volumes and the method(s) used to establish bolus delivery accuracy. For each bolus volume, pump accuracy shall be described in terms of the number of bolus doses measured to be within a given range as compared to the commanded volume. An acceptable accuracy description (depending on the drug delivered and bolus volume) may be provided as follows for each bolus volume tested, as applicable: Number of bolus doses with volume that is <25 percent, 25 percent to <75 percent, 75 percent to <95 percent, 95 percent to <105 percent, 105 percent to <125 percent, 125 percent to <175 percent, 175 to 250 percent, and >250 percent of the commanded amount. (iv) A description of the pump accuracy at minimum, intermediate, and maximum basal delivery rates and the method(s) used to establish basal delivery accuracy. For each basal rate, pump accuracy shall be described in terms of the amount of drug delivered after the basal delivery was first commanded, without a warmup period, up to various time points. The information provided must include typical pump performance, as well as worst-case pump performance observed during testing in terms of both over-delivery and under-delivery. An acceptable accuracy description (depending on the drug delivered) may be provided as follows, as applicable: The total volume delivered 1 hour, 6 hours, and 12 hours after starting delivery for a typical pump tested, as well as for the pump that delivered the least and the pump that delivered the most at each time point. (v) A description of delivery hazard alarm performance, as applicable. For occlusion alarms, performance shall be reported at minimum, intermediate, and maximum delivery rates and volumes. This description must include the specification for the longest time period that may elapse before an occlusion alarm is triggered under each delivery condition, as well as the typical results observed during performance testing of the pumps. (vi) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device. (vii) For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses. [87 FR 6424, Feb. 4, 2022] § 880.5735 Diabetes digital behavioral therapeutic device. (a) Identification. (b) Classification. (1) Design verification and validation must include documentation of: (i) Clinical data from a statistically and clinically justified sample size, fulfilling the following: (A) Appropriately validating the model of therapy as implemented by the device using a clinically defined endpoint, and (B) Demonstrating that use of the device does not adversely impact the health outcomes or health status of the intended use population. A device hazard analysis must consider all device-related adverse events observed from the clinical data collected and must demonstrate that patient risk from use of the device is minimal. (ii) Software verification, validation, and hazard analysis must demonstrate that the device performs as intended. (2) The labeling must include: (i) A summary of the clinical testing with the device, including a discussion of the limitations of the clinical significance of the results. (ii) Limiting statements that indicate: (A) The device is not intended for use as a standalone therapy. (B) The device is not a substitute for a patient's prescribed therapy or medication. (C) The device should not be used by people with unstable psychiatric disorders. (D) The device is not intended for use in the treatment of any psychiatric disorder or symptoms. [91 FR 46721, July 24, 2026] § 880.5740 Suction snakebite kit. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001] § 880.5760 Chemical cold pack snakebite kit. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 69682, Oct. 21, 1980, as amended at 52 FR 17739, May 11, 1987; 61 FR 50708, Sept. 27, 1996] § 880.5780 Medical support stocking. (a) Medical support stocking to prevent the pooling of blood in the legs Identification. (2) Classification. (b) Medical support stocking for general medical purposes Identification. (2) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001; 84 FR 71815, Dec. 30, 2019; 90 FR 55987, Dec. 4, 2025] § 880.5820 Therapeutic scrotal support. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001; 90 FR 55987, Dec. 4, 2025] § 880.5860 Piston syringe. (a) Identification. (b) Classification. § 880.5950 Umbilical occlusion device. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001] § 880.5960 Lice removal kit. (a) Identification. (b) Classification. [63 FR 59718, Nov. 5, 1998] § 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter. (a) Identification. (b) Classification. [65 FR 37043, June 13, 2000] § 880.5970 Percutaneous, implanted, long-term intravascular catheter. (a) Identification. (b) Classification. [65 FR 37043, June 13, 2000] Subpart G—General Hospital and Personal Use Miscellaneous Devices § 880.6025 Absorbent tipped applicator. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001; 90 FR 55987, Dec. 4, 2025] § 880.6050 Ice bag. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001; 90 FR 55987, Dec. 4, 2025] § 880.6060 Medical disposable bedding. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001; 90 FR 55987, Dec. 4, 2025] § 880.6070 Bed board. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001; 90 FR 55987, Dec. 4, 2025] § 880.6080 Cardiopulmonary resuscitation board. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001; 90 FR 55987, Dec. 4, 2025] § 880.6085 Hot/cold water bottle. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001; 90 FR 55987, Dec. 4, 2025] § 880.6100 Ethylene oxide gas aerator cabinet. (a) Identification. (b) Classification. § 880.6140 Medical chair and table. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001; 90 FR 55987, Dec. 4, 2025] § 880.6150 Ultrasonic cleaner for medical instruments. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001] § 880.6175 [Reserved] § 880.6185 Cast cover. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025] § 880.6190 Mattress cover for medical purposes. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025] § 880.6200 Ring cutter. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025] § 880.6210 Sharps needle destruction device. (a) Identification. (b) Classification. (1) Performance testing must demonstrate the following during operation of the device: (i) The device safely contains or ventilates aerosols or fumes from device operation. (ii) Excessive heat or sparks are not generated that may injure users or patients. (iii) Simulated use testing must demonstrate sharps and/or needles are completely destroyed using a range of types and sizes of sharps sufficient to represent actual use. (iv) Simulated use testing must demonstrate that the device is physically stable on the surface for which it is intended to be mounted to ensure the risk of harm to the patient/user as a result of the device falling is minimized. (2) Validation of cleaning and disinfection instructions must demonstrate that the device can be safely and effectively reprocessed after use per the recommended cleaning and disinfection protocol in the instructions for use. (3) Analysis and/or testing must validate electromagnetic compatibility and electrical safety, including the safety of any battery used in the device, under conditions which are consistent with the intended environment of device use. (4) Software verification, validation, and hazard analysis must be performed. (5) Labeling must include: (i) A clear description of the device and its technological features; (ii) How the device is to be used, including validated cleaning and disinfection instructions; (iii) Relevant precautions and warnings based on performance and in-use testing to ensure proper use of the device; and (iv) Instructions to install device in adequately ventilated area and stable area. [83 FR 19628, May 4, 2018] § 880.6230 Tongue depressor. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025] § 880.6250 Non-powdered patient examination glove. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 54 FR 1604, Jan. 13, 1989; 66 FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016; 84 FR 71815, Dec. 30, 2019] § 880.6260 Filtering facepiece respirator for use by the general public in public health medical emergencies. (a) Identification. (b) Classification. (1) Certification by the National Institute for Occupational Safety and Health (NIOSH) as a non-powered air-purifying particulate respirator with a minimum filtration efficiency classification of N95, in accordance with 42 CFR part 84. (2) The FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies.” See § 880.1(e) for information on obtaining a copy of this guidance document. [72 FR 36362, July 3, 2007] § 880.6265 Examination gown. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025] § 880.6280 Medical insole. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38806, July 25, 2001] § 880.6300 Implantable radiofrequency transponder system for patient identification and health information. (a) Identification. (b) Classification. [69 FR 71704, Dec. 10, 2004] § 880.6305 Ingestible event marker. (a) Identification. (b) Classification. (1) The device must be demonstrated to be biocompatible and non-toxic; (2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device; (3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and (4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions. [78 FR 28734, May 16, 2013] § 880.6310 Medical device data system. (a) Identification. (i) The electronic transfer of medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) The electronic display of medical device data. (2) An MDDS may include electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, and interfaces. This identification does not include hardware devices intended to be used in connection with active patient monitoring. Hardware devices for active patient monitoring are classified under other regulations and are not included in this regulation. (b) Classification. [76 FR 8649, Feb. 15, 2011, as amended at 86 FR 20283, Apr. 19, 2021] § 880.6315 Remote Medication Management System. (a) Identification. (b) Classification. [72 FR 59177, Oct. 19, 2007] § 880.6320 AC-powered medical examination light. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38806, July 25, 2001] § 880.6350 Battery-powered medical examination light. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025] § 880.6375 Patient lubricant. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001; 84 FR 71815, Dec. 30, 2019] § 880.6430 Liquid medication dispenser. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025] § 880.6450 Skin pressure protectors. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025] § 880.6500 Medical ultraviolet air purifier. (a) Identification. (b) Classification. § 880.6510 Whole room microbial reduction 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 performance characteristics must be tested: (i) Performance testing must demonstrate microbial log reduction of the demonstrated most resistant microorganism on medical device surfaces commensurate with the intended level of microbial reduction; (ii) Simulated use testing must evaluate device performance under simulated worst-case use conditions ( e.g., (iii) In-use testing must evaluate device performance under real-world use conditions; (iv) Performance testing must demonstrate the photobiological safety of any lamps or lamp systems; (v) Performance testing must evaluate safety features intended to prevent exposure and ensure that device operation can only occur in an unoccupied environment; and (vi) Performance testing must characterize the long-term material compatibility of the microbiocidal agent on clinically relevant surfaces and/or devices. (2) Biocompatibility testing must demonstrate safe residual levels of chemicals on medical devices surfaces and/or gaseous byproducts in air. (3) Software verification, validation, and hazard analysis must be performed for any software components. (4) Performance data must demonstrate the electromagnetic compatibility and electrical safety of the device. (5) Labeling must include: (i) Warnings and instructions to ensure the device is operated in an unoccupied environment; (ii) Setup and positioning instructions; and (iii) Information regarding material compatibility. [91 FR 57508, Sept. 10, 2026] § 880.6600 Ultraviolet (UV) radiation chamber disinfection device. (a) Identification. (b) Classification (1) Performance testing must demonstrate the following: (i) The chamber's ability to control the UV radiation dose during operation. (ii) The chamber's disinfection performance through microbial challenge testing. (iii) Evidence that the equipment intended to be processed is UV compatible. (iv) Validation of the cleaning and disinfection procedures. (v) The ability of the device to continue to perform to all specification after cleaning and disinfection. (vi) Whether the device generates ozone (if so, 21 CFR 801.415, Maximum acceptable level of ozone, applies). (2) Appropriate software verification, validation, and hazard analysis must be performed. (3) Appropriate analysis and/or testing must validate electrical safety, mechanical safety, and electromagnetic compatibility of the device in its intended use environment. (4) The labeling must include: (i) UV hazard warning labels. (ii) Explanation of all displays and/or labeling on user interface. (iii) Explanation of device safety interlocks. (iv) Explanation of all disinfection cycle signals, cautions and warnings. (v) Device operating procedures. (vi) Identification of the expected UV lamp operational life and instructions for procedures on replacement of the UV lamp when needed. (vii) Procedures to follow in case of UV lamp malfunction or failure. (viii) Procedures for disposing of mercury-containing UV lamps, if applicable. (ix) Identification of specific equipment that is compatible with the UV radiation dose generated by the device and that can safely undergo UV radiation low-level disinfection in the chamber device. (x) Description of the required preparation of equipment for disinfection in the UV radiation chamber device. (xi) Identification of the specific microbes used in successful performance testing of the device. (xii) Validated instructions for cleaning and disinfection of the device. [80 FR 72588, Nov. 20, 2015] § 880.6710 Medical ultraviolet water purifier. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 83 FR 25915, June 5, 2018] § 880.6730 Body waste receptacle. (a) Identification. (b) Classification. [66 FR 38806, July 25, 2001, as amended at 90 FR 55988, Dec. 4, 2025] § 880.6740 Vacuum-powered body fluid suction apparatus. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998] § 880.6760 Protective restraint. (a) Identification. (b) Classification. [61 FR 8439, Mar. 4, 1996, as amended at 66 FR 46952, Sept. 10, 2001; 84 FR 71815, Dec. 30, 2019] § 880.6775 Powered patient transfer device. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998] § 880.6785 Manual patient transfer device. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001; 90 FR 55988, Dec. 4, 2025] § 880.6800 Washers for body waste receptacles. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001; 90 FR 55988, Dec. 4, 2025] § 880.6820 Medical disposable scissors. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001] § 880.6850 Sterilization wrap. (a) Identification. (b) Classification. § 880.6855 Rigid sterilization container with electronic monitoring. (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 evaluated to ensure device function and integrity during challenging use: (i) Vent-to-volume testing must demonstrate adequate sterilant penetration. (ii) Sterilization validation must demonstrate that the contents to be sterilized can adequately achieve the proposed Sterility Assurance Level (SAL). (iii) Performance testing must demonstrate the device accurately informs the end-user of the sterile status of the contents. (iv) Performance testing must demonstrate the device can maintain sterility of the enclosed medical products for a minimum 30-day storage period. (v) Battery performance and shelf life testing must demonstrate the device maintains its function throughout its total use-life. (vi) Battery performance and shelf life testing must demonstrate the device maintains its function during storage, throughout a minimum 30-day sterile storage period. (vii) Moisture/sterilant ingress testing must support that the electronic components are adequately sealed and do not allow moisture/sterilant ingress. (viii) Microbial barrier testing must support that the seals, gaskets, valves, etc. provide an adequate barrier to microbial ingress. (ix) Seal integrity testing must demonstrate that an adequate seal is created and maintained throughout the sterile storage period. (x) Mechanical functionality testing must demonstrate proper function of any valves, gaskets, or other components essential to the function of the device. (xi) For devices with handles, handle strength testing must demonstrate the handles can withstand the maximum indicated load weight. (xii) Corrosion resistance testing must demonstrate adequate function of any components susceptible to corrosion following the most challenging use. (xiii) Dryness evaluation testing must demonstrate the contents to be sterilized are dry prior to storage. (xiv) Simulated use testing must evaluate device performance (including maintenance of sterility and accurate sterility status monitoring) under real-world worst-case use conditions. (2) Device components that may contact medical products must be demonstrated to be biocompatible. (3) Performance data must validate the reprocessing instructions for the reusable components of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) Human factors testing must be performed to demonstrate that end user(s) can safely and correctly use the device, based solely on the directions for use. (6) Performance data must demonstrate the electromagnetic compatibility and electrical safety of the device. (7) Labeling must include: (i) Warnings, cautions, and limitations for safe use of the device including: (A) A precaution that the lids/trays and any accessories should only be used with the sterilization container. (B) A precaution that the use of nonabsorbent tray liners can cause condensate to pool. (ii) Device operating procedures including: (A) Instructions for closures, gaskets, type, sizes, and valve assembly weight as appropriate. (B) Instructions for density and distribution of contents, stacking patterns, or any other recommendations pertaining to load configuration of the medical devices to be sterilized. (iii) A description of the validated length of time sterility can be maintained. (iv) Identification of any replaceable components, information about the expected life of these components, and instructions for procedures on replacement when needed. (v) Identification of products intended for sterilization that are compatible for use with the device. (vi) Description of the required preparation of products intended for sterilization in the device. [91 FR 32351, June 1, 2026] § 880.6860 Ethylene oxide gas sterilizer. (a) Identification. (b) Classification. § 880.6870 Dry-heat sterilizer. (a) Identification. (b) Classification. § 880.6880 Steam sterilizer. (a) Identification. (b) Classification. § 880.6885 Liquid chemical sterilants/high level disinfectants. (a) Identification. (b) Classification. [65 FR 36325, June 8, 2000] § 880.6886 Foam or gel chemical sterilant/high level disinfectant. (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 evaluated under challenging conditions: (i) Storage stability testing must demonstrate the real time stability and dynamics of the device formulation within the expiration date (shelf life) of the unopened product and within a use period of the opened container from the date of opening under the proposed storage conditions; (ii) Transport stability testing must demonstrate device resilience to transport conditions (such as temperature, pressure, and humidity), environmental factors (such as freeze and thaw), and mechanical impacts (such as the effect of drops on package integrity); (iii) Potency testing must demonstrate the sporicidal, mycobactericidal, fungicidal, bactericidal, and virucidal activities of the device; (iv) Simulated use testing must use the mycobacterium species most resistant to the germicide as the test organism on inoculated instruments to demonstrate a kill of at least 10 6 (v) In-use testing must test clinically-relevant microorganism on clinically used instruments, in accordance with the labeled contact conditions for high level disinfection, to confirm the results of simulated use testing; (vi) Testing must demonstrate compatibility with labeled devices and materials; and (vii) Chemical indicator validation must demonstrate a characteristic chemical reaction to the concentration of active ingredients of the germicide. (2) The device must be demonstrated to be biocompatible. (3) Human factors testing must demonstrate that the device can be used correctly, based solely on the device labeling. (4) Labeling must include: (i) Directions for use, including: (A) Instructions for preparation and use of the germicide; cleaning steps in preparation for high level disinfection; high level disinfections of cleaned devices; rinsing, neutralizing, and removing residues, when needed; and reuse of the solution, if applicable; and (B) Chemical indicator for monitoring the minimum effective concentration or minimum recommended concentration of the product's active ingredient(s); (ii) Instructions for personal protective equipment to be used with the device; (iii) Instructions for disposal of the germicide and any neutralizers, including an instruction to check local and state regulations; (iv) Storage conditions and expiration date information for stock solution, opened containers, activated solution, and use-dilution; (v) A statement that the end user should be trained in the reprocessing (decontamination and sterilization or disinfection) of medical devices and in the handling of toxic substances, such as liquid chemical germicides; (vi) The germicide classification scheme; (vii) General information on selection and use of germicides for medical device reprocessing; (viii) Material and device compatibility and incompatibility information; (ix) The microbial mode of action of germicidal activity; (x) Precleaning agent/method compatibility and incompatibility; and (xi) The toxicology profile of the final product formulation and information on adverse reactions following exposure to the product. [91 FR 38505, June 26, 2026] § 880.6887 Spore test strip. (a) Identification. 10 10 10 (b) Classification. (1) Spore strip characterization. 10 (ii) The resistance characteristics of the viable spores on the strip should be defined and be validated over the claimed shelf life. (iii) The spore strip description should address the carrier material, how the spores are placed on the carrier, and whether there is any feature that minimizes spore wash off. Bacteriostasis of the spore strip materials should be evaluated. (iv) Incubation time for viable spores on the strip should be validated under the specified incubation conditions over the claimed shelf life. (2) Simulated Use Testing. (3) Labeling. [87 FR 8194, Feb. 14, 2022] § 880.6890 General purpose disinfectants. (a) Identification. (b) Classification. [65 FR 36326, June 8, 2000] § 880.6900 Hand-carried stretcher. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001; 90 FR 55988, Dec. 4, 2025] § 880.6910 Wheeled stretcher. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998] § 880.6920 Syringe needle introducer. (a) Identification. (b) Classification. § 880.6960 Irrigating syringe. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001; 90 FR 55989, Dec. 4, 2025] § 880.6970 Liquid crystal vein locator. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38807, July 25, 2001] § 880.6980 Vein stabilizer. (a) Identification. (b) Classification. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001; 90 FR 55989, Dec. 4, 2025] § 880.6990 Infusion stand. (a) Identification. (b) Classification. [63 FR 59718, Nov. 5, 1998] § 880.6991 Medical washer. (a) Identification. (b) Classification. [67 FR 69121, Nov. 15, 2002] § 880.6992 Medical washer-disinfector. (a) Identification. (b) Classification. (1) Medical washer-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices. (2) Medical washer-disinfectors that are intended to clean, low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. [67 FR 69121, Nov. 15, 2002]