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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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P930014 S045
Current Protocol Accepted 10/25/2011
Study Name New Enrollment 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 Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, non-randomized, unmasked study, with data collection through electronic case report forms   show the rest ...
Study Population Description AcrySof® IQ Toric High Cylinder Power study group (IOL models

SN6AT6-SN6AT9), AcrySof IQ Aspheric Natural IOL   show the rest ...
Sample Size 215 subjects in the study group and 175 subjects in the control group

up to 80   show the rest ...
Data Collection Primary endpoint: rates of severe visual distortions as measured by the Assessment of Photic Phenomenon   show the rest ...
Followup Visits and Length of Followup Six months except those with Secondary Surgical Intervention (360-420 days).

Subjects will be followed up to   show the rest ...


New Enrollment PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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    
five year report 05/01/2016    
six year report 05/01/2017    

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