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GUIDANCE DOCUMENT

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

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Review and Update of Device Establishment Inspection Processes and Standards

Submit Comments by 05/28/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
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


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FDA is issuing this draft guidance to comply with section 702(b)(1) of the FDA Reauthorization 77 Act of 2017 (FDARA) (Public Law 115-52), which directs FDA to issue draft guidance that 78 specifies how the Agency will implement uniform processes and standards1 that are applicable to 79 inspections2 (other than for-cause) of foreign and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 This draft guidance also describes 83 standardized methods of communication during the inspection process, and identifies practices 84 for investigators and device establishments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.

Questions?

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