- In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
- The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
- CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
- In addition, CDRH launched a publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant’s reporting status for each submission due.
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
Procedures for Handling Post-Approval Studies Imposed by PMA Order Post-Approval Studies (PAS) - Frequently Asked Questions (FAQ) Letter to IRB Chairs Letter to PAS Participants Letter to PAS Investigators Report on Implementation of Post-Approval Studies for Medical Devices Workshop (June 2009)(PDF - 4.6MB) Post Approval Studies Status