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Export Certificate Denials for Medical Devices Can be Reviewed by FDA

Wednesday, November 20, 2019
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued a guidance on the information it will provide to those whose request for an export certificate for a medical device has been denied and the process for seeking a review of such a denial.

The so-called certificate to foreign government assures the governments of countries importing U.S. medical devices that such goods are in compliance with FDA rules. This guidance specifies the grounds on which the FDA may deny a request for a CFG, including seizures, recalls, and noncompliance with current good manufacturing practices, and requires the FDA to notify the exporter of the specific grounds on which its CFG request was denied.

If the denial was due to noncompliance, the exporter will be able to submit a plan of correction that identifies the remedial steps to be taken and when, and the FDA will attempt to respond within 90 days. If the plan is determined to be sufficient and a CFG application is under review, the FDA will issue the certificate if there is no other reason not to.

Exporters may also request a review of a CFG denial within 60 calendar days of the denial date. The guidance lays out the information that such requests should include; e.g., new information such as evidence that corrective actions are being or have been implemented.

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