Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations."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 has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. In an effort to promote timely clinical investigations in a manner that protects study subjects, FDA has developed methods to allow a clinical investigation to begin under certain circumstances, even when there are outstanding issues regarding the IDE submission. These mechanisms, including approval with conditions, staged approval or staged approval with conditions, and communication of outstanding issues related to the IDE through future considerations, are described in this guidance.