U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Center for Devices and Radiological Health
  5. CDRH Transparency
  6. Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
  1. CDRH Transparency

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report.

As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes. Links to all available summary review memos can be found in the searchable database linked below:

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes Database

This database is updated every Sunday.

 
Back to Top