522 Postmarket Surveillance Studies
WHAT: Design, Tracking, Oversight, Review of studies mandated under section 522, Federal Food, Drug and Cosmetic Act
WHY: To ensure well-designed 522 postmarket surveillance studies, conducted effectively and efficiently in the least burdensome manner
WHEN: Since 2008
WHO: Division of Epidemiology , Office of Surveillance and Biometrics, CDRH
HOW: CDRH Internal Tracking System, PUBLIC WEBPAGE