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.