Description
Thisguidanceprovides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices. This guidance document also provides recommendations for the content and review of premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications, concerning the labeling instructions for reprocessing reusable medical devices. Please note that exemption from 510(k) does not mean a device is exempt from compliance with labeling or Quality Management System Regulation (QMSR) requirements. Manufacturers of 510(k)-exempt devices should follow the recommendations of this guidance pertaining to such requirements, unless, for example, the device is specifically exempted by regulation from specific QMSR requirements.
Scope & Applicability
Product Classes
10A device intended for repeated use with appropriate cleaning and reprocessing.
Endoscopes requiring validation data if flexible
Example of a device with reprocessing safety signals
Flexible or rigid bronchoscopes and accessories
A device that is intended for one use or on a single patient during a single procedure.
Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
You should identify the device as reusable or reusable, after 24-hour multi-patient use
Many sterilization accessories used in reprocessing reusable devices in health care settings are class II medical devices; manufacturers must establish and maintain procedures for validating the design
devices contacting only intact skin
devices contacting intact mucous membranes or non-intact skin
Stakeholders
2Entity responsible for submitting NDINs
representative participants for validation studies
Regulatory Context
Attributes
5The expression extended cycle has gained common usage to describe any sterilization cycle that includes specifications that deviate
Quality parameter that must remain unchanged for the policy
Recommended level for device sterilization
Refers to device sizes with highest corrosion susceptibility or largest surface area.
The labeling should either 1) inform the user how many times the device can be reused
Identified Hazards
Hazards
7Prions requiring specific inactivation processes
High risk if devices are not adequately reprocessed
Risk associated with inadequately reprocessed devices
Labeling should include instructions for reducing sterilant residuals
risk of febrile reaction addressed by pyrogenicity testing
Delays may create conditions favorable to microbial growth
Environmental factors affecting biological products
Related CFR Sections (11)
- 21CFR870.4250§ 870.4250 Cardiopulmonary bypass temperature controller.
(a) Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.Read full regulation →
- 21CFR876.1500§ 876.1500 Endoscope and accessories.
(a) Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optRead full regulation →
- 21CFR874.4680§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a) Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light sourcRead full regulation →
- 21CFR880.6850§ 880.6850 Sterilization wrap.
(a) Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain Read full regulation →
- 21CFR880.2800§ 880.2800 Sterilization process indicator.
(a) Biological sterilization process indicator —Read full regulation →
- 21CFR820.3§ 820.3 Definitions.
The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.Read full regulation →
- 21CFR812.27§ 812.27 Report of prior investigations.
(a) General. The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation.Read full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR801.5§ 801.5 Medical devices; adequate directions for use.
Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specificatiRead full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments (Status: Final)
- CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases (Status: Final)
- Guidance Document For Washers And Washer-Disinfectors Intended For Processing Reusable Medical Devices (Status: Final)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers: Guidance for Industry (Status: Final)