Review and Update of Device Establishment Inspection Processes and Standards Guidance for Industry June 2020
- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Regulatory AffairsCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
FDA is issuing this guidance to comply with section 702(b)(1) of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which directs FDA to issue guidance that specifies how the Agency will implement uniform processes and standards that are applicable to inspections ( other than for-cause) of foreign and domestic medical device establishments. FDA updated processes and standards as needed, to address the new provisions in section 704(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that were added by FDARA section 702(a), and to establish a standard timeframe for inspections. This guidance also describes standardized methods of communication during the inspection process, and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.
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-2019-D-0914.