FDA Guidance Describes Process for Requesting Review of Denied Export Certificates

Posted November 19, 2019

The Food and Drug Administration (FDA) has issued final guidance describing the process an establishment must undertake if seeking review of a denied request for a Certificate to Foreign Government (CFG) for a medical device.

Foreign customers or governments often request that firms exporting products from the United States to supply a CFG for products regulated by the FDA. A CFG, explained the agency, is “a document prepared by FDA containing information about a product's regulatory or marketing status.”

In the guidance, titled Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices, the FDA listed several reasons why a CFG request may be denied:

  1. There is an injunction proceeding pursuant to section 302 of the Federal Food, Drug, and Cosmetic (FD&C) Act.
  2. There is a seizure action pursuant to section 304 of the FD&C Act.
  3. The device is the subject of a recall designated by the FDA as Class I or Class II (according to 21 CFR part 7).
  4. An establishment is out of compliance with FDA’s Quality System Regulation under 21 CFR part 820.

The agency detailed corrective actions that can be taken by firms that have received a “substantive summary of the specific grounds for noncompliance” corresponding with reason four above. The owner, operator, or agent in charge of the establishment can submit a plan of correction, which the FDA views as a response to inspectional observations issued under section 704(b) of the FD&C Act. Components of the plan of correction process include the following:

  • The plan of correction, which should be emailed to the FDA, must describe the steps the establishment is taking to address and prevent the recurrence of the inspectional observations, as well as the timeline for completing the actions. The plan also should document the corrective/preventive actions that have been and/or will be taken.
  • After reviewing the plan, the FDA will notify the establishment via email whether the plan is sufficient to address the documented violations or if further clarification is needed. The agency also said that its aim is to respond to plans of correction within 90 days.
  • If the FDA determines that the plan of correction is sufficient—and a CFG application is currently under review or subsequently has been submitted—it will issue a CFG “if no other grounds for denial are present.”

The FDA also provided guidance on situations in which a CFG is requested by a party that has a business relationship with an establishment that has a different owner/operator number. “If the CFG is denied because such establishment is found to be out of compliance,” wrote the agency, “the CFG requestor will receive a denial email indicating that the denial is based on matters pertaining to that establishment.”

Comments on the final guidance can be submitted to the FDA at www.regulations.gov, docket FDA-2018-D-2310.