Home » Pilot Would Reduce Audit Frequency Using Harmonized Regulations
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 It finalizes a draft guidance released in May 2010.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
The GMP Letter
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