FDA ISO 13485:2003 Pilot Program

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). 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. 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.

The program does have its limitations. 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. Eligibility is limited to domestic or foreign device manufacturers subject to FDA QSRs.

To participate in the pilot programs manufacturers must comply with the following requirements:
1. The audit report is submitted to the FDA within 90 days of the last day of the most recent ISO 13485:2003 audit;
2. The audit is performed using ISO 13485:2003: “Medical devices – Quality management systems – Requirements for regulatory purposes;” and,
3. The audit was performed by an auditor under one of the GHTF founding members regulatory systems:
a. The Canadian Medical Devices Conformity Assessment System (CMDCAS);
b. The European Union medical device Notified Body system;
c. The Therapeutics Goods Administration of Australia, Office of Manufacturing Quality; or
d. The Japanese Ministry of Health, Labour and Welfare system for Medical Devices and In-vitro Diagnostics.
4. The report must be consistent with GHTF Guidelines for QMS audits and Health Canada’s GD211: Guidance on the content of quality management system audit reports.

Momentum for the program’s initiation began with the publication of the “Final Joint Report of the Pilot Multipurpose Audit Program (PMAP)” which concluded that it is possible to conduct a single audit/inspection to satisfy the regulatory requirements of Health Canada and FDA. The program also provides the regulating bodies the opportunity to compare processes and seek out best practices in the regulatory oversight of medical device manufacturers. The goal of this program is to implement the single audit program over the next few years and, eventually, expand it across other GHTF partners.

-RTK