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Review and Update of Device Establishment Inspection Processes and Standards Draft Guidance for Industry March 2019


Not for implementation. Contains non-binding recommendations.

Docket Number:
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FDA is issuing this draft guidance to comply with section 702(b)(1) of the FDA Reauthorization 77 Act of 2017 (FDARA) (Public Law 115-52), which directs FDA to issue draft guidance that 78 specifies how the Agency will implement uniform processes and standards1 that are applicable to 79 inspections2 (other than for-cause) of foreign and domestic medical device establishments. FDA 80 updated processes and standards as needed, to address the new provisions in section 704(h)(1) of 81 the Federal Food, Drug, and Cosmetic Act (FD&C Act) that were added by FDARA section 82 702(a), and to establish a standard timeframe for inspections. This draft guidance also describes 83 standardized methods of communication during the inspection process, and identifies practices 84 for investigators and device establishments to facilitate the continuity of inspections of such 85 establishments.

Submit Comments

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.


Contact Point
ORA Office of Strategic Planning and Operational Policy (OSPOP)
Contact for guidance document questions