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GUIDANCE DOCUMENT

Review and Update of Device Establishment Inspection Processes and Standards Guidance for Industry June 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2019-D-0914
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Center for Devices and Radiological Health
Center 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.

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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:

Dockets Management
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.

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