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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 P080030
Current Protocol Accepted 05/13/2016
Study Name OSB Lead-New Enrollment Study
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Randomized Clinical Trial
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 Initial Phase:

Prospective, randomized, concurrently controlled, parallel group, multicenter investigation

Surgery consisting of implantation of   show the rest ...
Study Population Description Males or Females, 22 years of age or older

Sample Size 180 eyes of 180 subjects will comprise the treatment group. In addition, subjects randomized to   show the rest ...
Data Collection The primary endpoints will be the occurrence of STAEs. The STAEs include best corrected visual   show the rest ...
Followup Visits and Length of Followup Three years

Visit 1 Screening (day -60 to day -5)

Visit 2 Baseline (after completion   show the rest ...

OSB Lead-New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 12/24/2012 12/26/2012 Overdue/Received
one year report 06/25/2013 06/25/2013 On Time
18 month report 12/24/2013 01/27/2014 Overdue/Received
two year report 06/25/2014 06/17/2014 On Time
three year report 06/25/2015 06/24/2015 On Time
four year report 06/24/2016 06/22/2016 On Time
five year report 06/24/2017    

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