Medical device manufacturers may gain a one-year exemption from Food and Drug Administration (FDA) inspections if their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using ISO 13485. Manufacturers must submit the audit results to the FDA voluntarily. From the audit results, the FDA determines whether to inspect that establishment for one year.

In a draft guidance issued on May 20, the “Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program,” the FDA describes how its Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research are implementing section 228 of the Food and Drug Administration Amendments Act of 2007.

According to provision F of section 228, “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.” It further specifies that if the owner or operator of an establishment chooses to submit audit reports, the owner/operator “shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.”

Audit reports must provide “a degree of assurance of compliance with basic and fundamental quality management system requirements for medical devices.” If the FDA determines there is minimal probability that the establishment will produce nonconforming and/or defective finished devices based on “the relationship between the quality system deficiencies observed and the particular device and manufacturing processes involved,” then it will use the audit results in determining whether to remove that establishment from its routine work plan for one year. However, inspections conducted “for cause” will not be affected.

Any device manufacturer will be eligible for this exemption if its facilities have been audited under any of four regulatory systems using ISO 13485 —“Medical devices—Quality management systems—Requirements for regulatory purposes.” These GHTF regulatory systems are identified in the draft guidance as the Canadian Medical Devices Conformity Assessment System, the European Union Notified Body accreditation system, the Therapeutics Goods Administration of Australia Inspectorate, and the Japanese Medical Device Ministry of Health, Labour and Welfare system.

This draft guidance may be downloaded from the FDA website at www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments.

For help in determining your organization’s eligibility for this exemption, visit STAT-A-MATRIX or call (800) 472-6477.