FDA and ISO 13485

The Food and Drug Administration (FDA) has issued the Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program and it is expected to go live in June 2012.

The ten page guidance document shares the FDA framework for manufacturers, in good compliance with QMS / QSR requirements, to voluntarily submit ISO 13485 reports and certifications to the FDA. This will allow the FDA to remove the manufacturer from the FDA inspection schedule for 12 months.

This guidance provides information on the implementation of section 228 of the FDA Amendments Act of 2007, Public Law 110-85, which amended section 704(g)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374 (g)(7)). Section 228 was amended to add the following provision:

“(F) For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.”

A device manufacturer whose establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using International Organization for Standardization (ISO) 13485:2003, with Technical Corrigendum 1:2009, “Medical devices – Quality management systems – Requirements for regulatory purposes,” may voluntarily submit the resulting audit report to FDA.

If, based on that report, FDA’s analysis or compliance decision meets the requirements of the FDA’s Medical Device Compliance Program 7382.845 for “Situation II,” that there is minimal probability — in light of the relationship between the quality system deficiencies observed and the particular device and manufacturing processes involved — that the establishment will produce nonconforming and/or defective finished devices, then FDA intends to use the audit results as part of its risk assessment to determine whether that establishment can be removed from FDA’s routine inspection work plan for one year from the last day of the ISO 13485:2003 audit.

The effect of removal from the routine inspection work plan is that FDA intends to postpone the establishment’s bi-annual inspection for that one-year period. The voluntarily submitted ISO 13485:2003 audit report provides FDA some information on the conformance of the manufacturer with basic and fundamental quality management system requirements for medical devices.

Inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this pilot program. Moreover, this pilot program would not apply to any necessary pre-approval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the FD&C Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device.

It is important to note that participation in the Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program is entirely voluntary. FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required.

FDA is currently working with Health Canada to implement a single audit program over the next few years and is also looking forward to expanding this single audit program in the future to other GHTF partners. The Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program outlined in the guidance document is another way in which FDA may leverage audits performed by other GHTF regulators and their accredited third parties in order to assist the agency in setting risk-based inspectional priorities.

For more information on Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program, and answers to these questions:

  • Who is Eligible to Participate?
  • What Audit Reports are Eligible for Submission Under the Program?
  • How Should the Manufacturer Submit the Eligible ISO 13485:2003 Audit Reports?
  • What Will FDA Do With the Submissions?

Download the PDF guidance document at this FDA web page.