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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 P980040 S039
Current Protocol Accepted 08/25/2015
Study Name OSB Lead-New Enrollment of Post Approval Study
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 Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this post-approval study is to evaluate the rates of visual distortions for   show the rest ...
Study Population Description Patients with bilateral cataracts with corneal astigmatism of approximately 2.00 D to 3.62 D based   show the rest ...
Sample Size Up to 435 subjects will be enrolled to achieve bilateral implantation in approximately 385 subjects:   show the rest ...
Data Collection Primary Endpoint

Rate of severe visual distortions; defined as the percentage of subjects who report a   show the rest ...
Followup Visits and Length of Followup Six months; any subjects that undergo a lens repositioning

procedure due to IOL misalignment or that   show the rest ...

OSB Lead-New Enrollment of Post Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 10/14/2013 11/20/2013 Overdue/Received
one year report 04/15/2014 04/15/2014 On Time
18 month report 10/14/2014 10/23/2014 Overdue/Received
Validation phase report 02/06/2015 02/06/2015 On Time
two year report 04/15/2015 04/15/2015 On Time
three year report 04/14/2016 04/13/2016 On Time
four year report 04/14/2017    
five year report 04/14/2018    

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