Nov 11, 2020

The US FDA has published the final version of the guidance document “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices.”

This document was issued in response to section 704 of the FDA Reauthorization Act of 2017 (FDARA), which amended section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide review options available to manufacturers who are denied a Certificate to Foreign Government (CFG). One of the numerous export certificates issued by the FDA, a CFG authorizes the export of drugs or medical devices that are already legally marketed in the US.

The guidance describes the information that will be provided to the manufacturer by the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Regulatory Affairs (ORA), in case of a CFG request denial. It also outlines how to pursue review of a denial with the FDA.

Guidance document explains CFG denials and two options for requesting review

In the guidance, the FDA lists possible grounds for a CFG denial and explains how to prepare and submit a “plan of correction,” which demonstrates that the manufacturer has addressed the problem(s) that caused the denial and can lead to a subsequent approval. This has previously been the expected course of action for manufacturers to respond to denials.

The latter part of the guidance document outlines two distinct processes available for review of a CFG denial, given under the headings “Review Pursuant to Section 801(e)(4)(E)(ii)(I)” and “Review of New Information Pursuant to Section 801(e)(4)(E)(ii)(II).” As indicated by these titles, the first review process is meant to dispute the grounds for denial given the previously submitted documentation, while the second utilizes new information expected to potentially change the FDA’s decision.

A draft version of this guidance was first published in November 2019. The document provides comprehensive information on submission deadlines, expected review timeframes, pertinent FDA contacts, and links to further FDA guidances.

Learn more about US FDA medical device regulations at Emergo by UL:

  • Obtaining a CFG from the US FDA
  • FDA submission support for medical devices and IVDs
  • Whitepaper: Medical device testing requirements for FDA 510(k) submissions
  • Whitepaper: Early communication with the US FDA

Author

  • Timothy Herr

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