FDA Issues Final Export Certificate Guidance, Explains What To Do If Your Firm Is Turned Down For One
An 8-page final guidance from the US agency lays bare reasons why it would deny an export certificate to a company. It also explains how a firm can appeal if it is turned down for a certificate. The guidance was developed because the FDA Reauthorization Act of 2017 – FDARA – required the agency to provide a rationale when it turns down a request for a Certificate to Foreign Government (CFG), including listing any specific grounds for a finding of noncompliance.
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The agency has issued a notice explaining how products that do not qualify for an export certificate may still get a Certificate for Device Not Exported when marketing outside the US.
New US FDA draft guidance attempts to clarify when and why the agency might deny device manufacturers an export certificate, as well as the review process to appeal such denials.
US Regulatory Roundup, February 2021: QA/RA Predictions, FDA Warning Letter Stats, PMA Case Study, And More
Quality and regulatory predictions for 2021, a count of 2020 US FDA enforcement missives, a premarket approval case study for a novel prosthetic, and more topped our list of most-read Medtech Insight articles in February.