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 December 2019
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological Health
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1998-D-0281.