PMA Approval Posts

New Guidance on Postmarket Surveillance from the FDA

Mark Crawford

The FDA continues to roll out new guidance documents for medical device regulations—this time presenting updated rules for postmarket surveillance.
The draft entitled “Postmarket Surveillance under Section 522 of the Federal Food, Drug and Cosmetic Act,” released by the FDA on August 16, provides a summary of the revised postmarket surveillance program, including new modifications. (more…)