PMA Summary Review Database Now Available from CDRH
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has launched a new searchable database of premarket approval (PMA) summary review memos.
The CDRH defines 180-day supplements as requests for significant changes in components, materials, design or other factors to a previously approved premarket application or report. The new database specifically provides information on PMA summary review memos for 180-day design changes.
The database is part of the CDRH Transparency Initiative, a pilot program launched by the FDA. Updates to the database will occur every Sunday, according to the agency.