Post-Approval Studies

Post-Approval Studies

• 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 this 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.

Links

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Webpage FAQs
• IRB Letter from Dr. Schultz (dated 2/9/09)

Contact Information

Nicole Jones
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD
20993-0002

Phone: (301) 796-6062
Fax: (301) 847-8140
nicole.jones@fda.hhs.gov

Show All Studies Export to Excel Application Number Post-Approval Study Commitment Study Name Protocol Approved Study Population Study Status P020016 POSTAPPROVAL STUDY IN ORDER TO OBTAIN ADDITIONAL LONG TERM SAFETY AND EFFECTIVENESS DATA. THREE YEAR FOLLOW-UP DATA WILL BE COLLECTED ON SUBJECTS WHO WERE ENROLLED IN THE CLINICAL STUDY, BUT DID NOT COMPLETE FOLOW-UP PRIOR TO PMA APPROVAL THIS POSTAPPROVAL STUDY WILL BE PERFORMED IN ACCORDANCE WITH THE AGREED UPON PROTOCOL SUBMITTED IN AMENDMENT 17 OF THE PMA SUBMISSION DATED 1/11/05. REPORTS WILL BE SUBMITTED ANNUALLY. ADDITIONALLY, THE LABELING WILL BE UPDATED, VIA A SUPPLEMENT, AT THE COMPLETION OF THE STUDY.   Longterm Followup Study 09/21/2005 Transitional Adolescent B: 18-21 yrs, Adult: >21 Progress Adequate

Longterm Followup Study Schedule

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