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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 August 2018

Draft

Not for implementation. Contains non-binding recommendations.

Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices

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

The FDA is issuing this draft guidance document to comply with section 704 of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which amended section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to specify the process afforded to persons denied a Certificate to Foreign Government (CFG) for a device.

This guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial.


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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.