FDA ISO 13485 Voluntary Audit Report Submission

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FDA CDRH is kicking off their ISO 13485:2003 Voluntary Audit Report Submission Pilot Program June 5, 2012.  FDA wants to explore how they can leverage off of some of the ISO 13485 audits being conducted by ISO conformity assessment bodies.

The premise of the 13485 Voluntary Audit Report Submission Program was based on an amendment to the law, which is in Section 228 of the FDA Amendment, and it basically tells FDA that they can accept voluntary submissions of ISO reports for purposes of setting risk-based inspectional priorities.  With a satisfactory audit report indicating a manufacturer’s Quality System is acceptable,  FDA could utilize this information for risk-based work load planning for determining where to take their resources for inspections.

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