Post-Approval Studies Background
The FDA may require a post-approval study (or studies) at the time of approval of a Premarket Approval (PMA), Humanitarian Device Exemption (HDE), or product development protocol (PDP) application to help assure continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of the approved device. Post-approval studies (PAS) are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for withdrawing approval.
CDRH’s Post-Approval Studies Program ensures that methodologies are well-designed and conducted effectively, efficiently and in the least burdensome manner. In 2005, the Division of Epidemiology (DEPI) in CDRH’s Office of Surveillance and Biometrics (OSB) assumed responsibility for overseeing the program. Along with OSB, other CDRH offices including the Office of Device Evaluation (ODE), and the Office of In-Vitro Diagnostics and Radiological Health (OIR), share PAS Program responsibilities for design, tracking, oversight, and review of these mandated studies.
CDRH has established the Post-Approval Studies Database to share general information regarding each PAS ordered since January 1, 2005, provides the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant’s current reporting status for each submission due. The database refreshes every Sunday with any new or revised information on study protocol parameters (e.g., patient population), overall study status, or information related to the review of data from interim or final reports.
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Phone: (301) 796-6134, Fax: (301) 847-8140