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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.

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