Issue Date: December 16, 2019
Issued by: Center for Biologics Evaluation and Research
Topic(s): Premarket, Administrative / Procedural, Device & Drug Safety, HUD/HDE, Premarket Approval (PMA)
Status: Final
30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff
Section 515(d)(6)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) provides that PMA supplements are required for any change to a device subject to an approved application that affects safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacturing. 21 U.S.C. 360e(d)(6)(A). The Act states that changes in manufacturing procedures or method of manufacturing that affect safety or effectiveness require a 30-day notice. Where FDA finds such notice inadequate, FDA will inform the applicant that a 135-day PMA supplement or 75-day HDE supplement must be submitted. 21 CFR 814.39(f), 814.108. The purpose of this document is to provide guidance on the changes FDA believes may qualify for the 30-day notice and the changes that generally do not qualify. This document replaces the guidance entitled, “30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes,” issued February 19, 1998. This new guidance includes updates to reflect the current review process, additional examples of manufacturing changes that may be submitted under this program, and a discussion of user fees.
Download the Guidance Document
