Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket Approval Supplements and 75-Day Humanitarian Device Exemption Supplements for Manufacturing Method or Process Changes; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes." This document provides guidance on the type of changes to an approved application that FDA believes may qualify for submission as 30-day notices, the type of information to submit in a 30-day notice, and the user fees associated with these submissions. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices (GGP).