Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Medical Devices: The Pre- Submission Program and Meetings with FDA Staff." The purpose of this guidance is to describe the Pre-Submission program (formerly the pre- Investigational Device Exemption (IDE) program) for medical devices reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). 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 industry representatives or application sponsors request a meeting with review staff. This draft guidance is not final nor is it in effect at this time.