- Docket Number:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
The purpose of these instructions is to assist FDA field personnel in applying the device GMP regulation to inspections of manufacturers of sterile devices. File these instructions with CP7378.830 "Inspection of Medical Device Manufacturers" (10-24-83) for reference when conducting GMP inspections of sterile device manufacturers. The examples given concern conditions, procedures and methods that can directly affect sterility specifications. The examples are not intended to cover all possible variations in sterilization practices, and may not apply in all situations. They are general factors for the use in determining whether a manufacturer's production procedures and sterilization processes are in compliance with the GMP regulation.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.