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GUIDANCE DOCUMENT

Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria Guidance for Industry, FDA Staff, and Third Parties August 2009

Final
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The FDA Reauthorization Act of 2017 (FDARA), signed into law on August 18, 2017, amended several sections of the Federal Food, Drug, and Cosmetic Act. This document was developed and issued prior to the enactment of FDARA, and certain sections may no longer be current as a result. FDA is assessing how to revise this document to represent our current thinking on this topic. For more information please contact CDRH-FDARA@fda.hhs.gov.


This guidance addresses section 704(g) of the Federal Food, Drug, and Cosmetic Act (FDCA or the act) (21 U.S.C. 374(g)(2)) which concerns the accreditation of third parties (Accredited Persons) to conduct inspections of eligible manufacturers of class II and class III medical devices.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.

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