Good Deal? Firms Seek Details On FDA ISO Audit Report Submission Program
This article was originally published in The Gray Sheet
Executive Summary
Device makers generally support FDA's plan for accepting voluntary international audit reports as a means for possibly delaying an FDA inspection, but firms say more details need to be spelled out before many will agree to participate
You may also be interested in...
CDRH Prepares For Electronic Recall Submissions; Pre-Market Still A Challenge
Device recall reports may be submitted via FDA’s eSubmitter platform beginning in the coming months. Meanwhile, full-fledged electronic submissions of pre-market device applications are still a ways off.
Draft Guidance: Clean ISO Audit Report May Permit Delayed FDA Inspections
Device companies may be able to put off an FDA facility inspection if the plant has recently satisfied international quality system standards, according to a 1draft guidance released by the agency May 20
FDA Will Inspect Firms That Didn’t Participate In U.S.-Canada Program
Manufacturers that turned down FDA's offer to participate in its Pilot Multipurpose Audit Program (PMAP) will soon be inspected by the agency, CDRH's compliance chief says