FDA Asks Industry for More Info on Manufacturing Changes

FDA officials sounded a familiar drumbeat during an Aug. 27 meeting on ways to notify the agency about changes to PMA products, asking devicemakers to submit more complete information upfront to ensure their submissions can be processed quickly. The joint FDA-AdvaMed meeting at the agency’s White Oak, Md., headquarters was held in advance of a planned pilot program that will transfer reviews of cardiovascular device submissions, such as annual reports and 30-day notices, from the Office of Compliance to the Office of Device Evaluation.
The GMP Letter