Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations." This guidance document was initially issued in draft on November 10, 2011, and was developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. The guidance was also intended to provide clarification regarding the regulatory implications of the decisions that FDA may render based on review of an IDE and to provide a general explanation of the reasons for those decisions. This guidance has been revised and is being reissued for comment because the Food and Drug Administration Safety and Innovation Act (FDASIA), which became law on July 9, 2012, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to specify certain situations in which FDA cannot disapprove an IDE. This draft guidance is not final nor is it in effect at this time.