Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program." This draft guidance is intended to provide information on the implementation of a section of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amends a section of the Federal Food, Drug, and Cosmetic Act (the act). This guidance document describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this provision of the law. This draft guidance is not final nor is it in effect at this time.