The audit report is submitted to the FDA within 90 days of the last day of the most recent ISO 13485:2003 audit Ģ. To participate in the pilot programs manufacturers must comply with the following requirements:ġ.

Eligibility is limited to domestic or foreign device manufacturers subject to FDA QSRs. Voluntary submittal of the ISO 13485:2003 audit report will have no effect on the FDA’s intention to visit the medical device manufacturer for pre-approval or post approval inspections for Premarket Approval (PMA) applications, decisions under section 513(f)(5) of the FD&C Act, “For Cause” audits or “Compliance Follow-up” by the FDA. The FDA will then use the audit result as part of its risk assessment to determine whether the manufacturer can be removed from the FDA’s routine inspection plan for one year from the last day of the ISO 13485:2003 audit. Said audit reports will be reviewed by the FDA to determine whether the nonconformances observed within its contents suggest that the establishment will produce nonconforming and/or defective devices.

Effective June 5, 2012, FDA will begin a voluntary pilot program to accept voluntary submissions of external audit reports compiled by one of the founding members of the Global Harmonization Task Force (GHTF).

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