FDA Takes Steps to Align with GHTF

In June 2012, the United States Food and Drug Administration will pilot a program allowing medical device manufacturers to submit ISO 13485:2003 quality system audits to satisfy the FDA 21 CFR Part 820 inspection requirements for one year.


The FDA currently requires that all foreign and domestic medical device manufacturers comply with CFR Part 820, Good Manufacturing Practices. Allowing manufacturers to avoid FDA inspections for one year via the ISO 13485 audits, the agency is attempting to align with Global Harmonization Task Force guidelines. The FDA will review the findings of the ISO 13485 audits, and if found acceptable, the manufacturer will be removed from the FDA audit schedule “from the last day of the most recent ISO 13485 audit.”

For more information, visit the Emergo Group: http://www.emergogroup.com/

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