Devicemakers Wait for FDA to Issue Closeout Letters

Nearly five months after the FDA began its closeout letter program, the agency has issued only one letter for a medical product, leaving companies wondering when they can expect to receive the official stamp of approval that clears them of concerns raised in warning letters. When a closeout letter is issued, it also is posted to the FDA’s website — a step devicemakers say is critical in demonstrating to customers, investors and international regulatory agencies that they are in compliance with FDA regulations.
Devices & Diagnostics Letter