Guidance Released for FDA ISO 13485 Pilot Program

As part of a professed effort to align its regulatory practices more closely with those of Global Harmonization Task Force (GHTF) members, the US Food and Drug Administration is set to implement a new pilot program whereby medical device manufacturers may choose to submit audits of their quality systems compliant with ISO 13485:2003 to the FDA’s Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER).

If FDA reviewers determine that information in a manufacturer’s voluntarily submitted ISO 13485 audit indicates that the firm will not likely produce defective or nonconforming devices, that manufacturer may be relieved of FDA quality system audit requirements for one year.

Any US-based or foreign manufacturer subject to 21 CFR Part 820 requirements is eligible to participate in the new program, under the following conditions:

  • The manufacturer must submit its ISO 13485 audit report to the FDA within 90 days of the audit’s conclusion
  • Audits are performed according to ISO 13485:2003 “Medical devices – Quality management systems – Requirements for regulatory purposes” rules
  • ISO 13485 auditors involved must comply with regulations of a GHTF founding member: Canada, the European Union, Australia or Japan


A qualifying submission to the FDA must include an ISO 13485 audit and audit report satisfying GHTF guidelines; the manufacturer must also submit all ISO 13485 audit reports from the previous two years, its current ISO 13485 certificae, as well as contact details (or those of any authorized US FDA agents), relevant FDA registration numbers and ISO 13485 auditor information. All data submitted to the FDA must be in English, in PDF format, and sent to the FDA via the agency’s eSubmitter system.

If an ISO 13485 data submission is deemed acceptable by FDA reviewers, they will recommend that the manufacturer in question “be removed from the routine work load plan for one year from the last day of the most recent ISO 13485:2003 audit,” according to the guidance. The pilot program officially begins June 5, 2012.

The FDA officially still accepts only quality systems compliant with 21 CFR Part 820 (FDA Good Manufacturing Practice) for medical devices marketed in the US. But this new guidance coincides neatly with the agency’s plan to develop in partnership with Health Canada a single audit program for both the US and Canada—and potentially to expand that program to other GHTF member states. In the meantime, manufacturers having to meet both FDA GMP and ISO 13485 quality system requirements will at least have the chance to reduce their US quality system inspection timetables. 

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