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Guidance Issuing OfficeCenter 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.
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-2003-D-0304.