Business · 17/08/2018

FDA Publishes Draft Guidance on Requesting Review of Export Certificate Denial for Devices

The Food and Drug Administration (FDA) has released a draft guidance outlining the process for requesting a review of denied export certificates for medical devices, in response to changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA Reauthorization Act of 2017 (FDARA).