FDA'S PILOT INSPECTION PROGRAM TO BECOME PERMANENT, AGENCY'S CHESEMORE TELLS HIMA; EIRs WILL AUTOMATICALLY BE ISSUED TO MANUFACTURERS BEGINNING IN APRIL
This article was originally published in The Gray Sheet
Executive Summary
FDA's pilot pre-announced inspection program for device manufacturers is being made permanent, Ronald Chesemore, the agency's associate commissioner for regulatory affairs, told attendees at the Health Industry Manufacturers Association annual meeting March 16 in St. Petersburg, Florida. Encouraged by favorable feedback from FDA inspectors and industry, the agency has decided to implement the initiative as a "permanent change in our medical device program," Chesemore said.