Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings With Food and Drug Administration Staff; Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staff." The purpose of this guidance is to provide an overview of the mechanisms available to application sponsors through which to obtain FDA feedback regarding potential or planned medical device submissions reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), including the Pre-Submission program (formerly the pre-Investigational Device Exemption (pre-IDE) program). In addition, the guidance provides recommendations regarding information that should be included in a Pre- Submission Package. This guidance also describes the procedures that CDRH and CBER intend to follow when manufacturers, their representatives, or application sponsors request a meeting with review staff.