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In a draft guidance issued on May 20, the “Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program,” the FDA describes how its Center for Devices and Radiological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.

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