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U.S. Department of Health and Human Services

Post-Approval Studies

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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.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P130004
Current Protocol Accepted 10/02/2014
Study Name OSB Lead-Clinical PAS
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description To collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract   show the rest ...
Study Population Description Adult patients undergoing cataract surgery using the surgeon¿s standard techniqu treated with ReSure Sealant.   show the rest ...
Sample Size A sample size of 598 achieves an alpha of 0.05 and 80% power to detect   show the rest ...
Data Collection The primary endpoints will be the following Adverse Ocular Events occurring in the postoperative follow-up   show the rest ...
Followup Visits and Length of Followup 4 weeks post-procedure

Subjects will be evaluated in the immediate postoperative period (Visit 1: Day 1   show the rest ...

OSB Lead-Clinical PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 07/09/2014 07/28/2014 Overdue/Received
one year report 01/08/2015 01/08/2015 On Time
18 month report 07/09/2015 07/08/2015 On Time
two year report 01/08/2016 12/28/2015 On Time
Final Report 06/30/2016 06/30/2016 On Time
three year report 01/07/2017    
four year report 01/07/2018    
five year report 01/07/2019    

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