MEDICAL DEVICE EXPORT APPROVAL FDA GUIDANCE UNDER DEVELOPMENT
This article was originally published in The Gray Sheet
Executive Summary
MEDICAL DEVICE EXPORT APPROVAL FDA GUIDANCE UNDER DEVELOPMENT will describe the safety data requirements necessary to gain FDA clearance to export under Sec. 801 (e) of the Food, Drug and Cosmetic Act, device center Office of Compliance Director Ronald Johnson stated March 23 at the Health Industry Manufacturers Association annual meeting in Boca Raton, Florida. The device center is hoping to finish the guidance by July or August, FDAers say.