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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 P930014 S045
Current Protocol Accepted 09/18/2015
Study Name OSB Lead-New Enrollment PAS
Study Status Completed
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 primary objective of this study is to demonstrate superiority of the AcrySof® IQ Toric   show the rest ...
Study Population Description Adult subjects in need of bilateral cataract surgery with pre- operative corneal astigmatism in the   show the rest ...
Sample Size Total Sample size: 400

-AcrySof® IQ Toric IOL Model SN6AT6-SN6AT9: 230

-AcrySof® IQ Aspheric NATURAL IOL Model   show the rest ...
Data Collection The primary safety endpoint for this study is the rates of severe visual distortions as   show the rest ...
Followup Visits and Length of Followup Six months, except those with Secondary Surgical

Intervention (360-420 days).

OSB Lead-New Enrollment PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 11/01/2011 11/30/2011 Overdue/Received
interim report 02/09/2012 02/09/2012 On Time
one year report 05/02/2012 05/03/2012 Overdue/Received
18 month report 10/31/2012 11/01/2012 Overdue/Received
two year report 05/02/2013 04/29/2013 On Time
three year report 05/02/2014 05/22/2014 Overdue/Received
wrong report 05/19/2014 05/19/2014 On Time
four year report 05/02/2015 06/10/2015 Overdue/Received
Final Report/5 yr report 05/01/2016 04/13/2016 On Time

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