FDA bids to overhaul "inefficient" foreign inspections
This article was originally published in Clinica
Executive Summary
The US FDA is preparing to revamp the way it conducts premarket inspections at overseas manufacturing facilities after hearing about hold-ups that can result in costly delays for manufacturers. Compliance officers met last week to discuss the programme's current problems and what to do about them, Tim Ulatowski, director of the office of compliance in FDA's device centre (CDRH), told AdvaMed's Device Submissions Workshop on June 3.