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GUIDANCE DOCUMENT

Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices Guidance for Industry and Food and Drug Administration Staff November 2023

Download the Final Guidance Document
Final
Docket Number:
FDA-2018-D-2310
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

FDA is issuing this guidance to make minor updates to align with section 3304 of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-32, which directs FDA to provide certification for devices that are not exported from the United States (CFG-NEs). This guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Regulatory Affairs (ORA), will provide to a person whose request for a Certificate to Foreign Government (CFG) for a device is denied, and the process for seeking review of such a denial. The updated guidance explains that the processes referenced in the guidance apply to CFG-NEs as well as CFGs, pursuant to FD&C Act section 801(e)(4)(F)(iv), unless otherwise specified.

Submit Comments

Submit Comments Online

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-2018-D-2310.

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