Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Types of Communication During the Review of Medical Device Submissions." The purpose of this guidance is to update the Agency's approach to Interactive Review to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed in connection with the Medical Device User Fee Amendments of 2012 (MDUFA III) and to incorporate additional types of communication, all of which increase the efficiency of the review process. This draft guidance is not final nor is it in effect at this time.