FDA Issues Guidance on ISO 13485 Voluntary Audit Program

On March 19, 2012 FDA issued a guidance document setting up the program for voluntary submission of ISO 13458 audit reports. See UCM212798. By submitting two years of acceptable ISO 13485 audit reports, FDA can remove the firm from the routine inspection work plan for one year. Current law requires an FDA inspection for Class II and Class III device manufacturers once in every two-year period.

A device manufacturer can participate under the following conditions

  • The firm submits the audit report within 90 days of the audit
  • The audit uses ISO 13485:2003
  • The auditor is under the regulatory system of Canada, the European Union, Australia, or Japan

The firm submits two years of documentation including the audit report, any related correspondence or communication, and a copy of the ISO 13485 certificate. The documentation must be PDF files submitted electronically through the “FDA eSubmitter” system.