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.

 

Posted on the FDA website on 14 January 2013