Device export policy
This article was originally published in The Gray Sheet
Executive Summary
A device never marketed in the U.S. and without 510(k) clearance does not require an export approval from FDA if the manufacturer has reason to believe the product would be deemed "substantially equivalent," FDA staffers report. The policy supersedes the position taken in FDA's August 1992 publication "Everything You Always Wanted to Know About Medical Device Requirements...and Weren't Afraid to Ask," which specified that such devices must receive export approval letters. The agency's new interpretation is in line, however, with the policy expressed in its August 1990 "Export of Medical Devices: A Workshop Manual"