Pilot Would Reduce Audit Frequency Using Harmonized Regulations

Starting June 5, devicemakers audited according to internationally harmonized regulatory standards could be spared some annual FDA inspections, under a pilot program described in a final guidance. The agency published the guidance on Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program in the March 19 Federal Register. It finalizes a draft guidance released in May 2010.
The GMP Letter