On August 16, 2018, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) announced (by tweet!) that it was issuing a draft guidance that provides information regarding new processes associated with FDA’s denial of requests for Certificates to Foreign Government (CFGs). FDA, Draft Guidance, Process to Request a Review of FDA’s DecisionNot to Issue Certain Export Certificates for Devices (Aug. 17, 2018) (hereinafter “CFG Draft Guidance”). The draft guidance was issued in compliance with § 704 of the FDA Reauthorization Act of 2017 (FDARA), P.L. 115-52, which required the Agency to issue the document in draft form by August 18, 2018. The draft guidance provides important clarity to industry on the Agency’s implementation of FDARA’s statutory changes regarding (1) the information to be supplied to CFG applicants whose requests are denied, (2) the potential bases for CFG denials, and (3) the review process for CFG denials.

By way of background, foreign governments often seek assurance from FDA that products exported to their countries from the United States comply with U.S. laws and regulations, such as the Quality System Regulation (QSR) in 21 C.F.R. Part 820. FDA supplies this reassurance in the form of CFGs, which industry must request directly from the Agency. FDARA and the draft guidance identify four potential reasons that FDA may deny a request, although the draft guidance does not limit FDA to these four categories of denials...