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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 H110002
Current Protocol Accepted 09/18/2015
Study Name OSB Lead-New Enrollment Argus II
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met
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 Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description New Enrollment Post-Approval Study: Multicenter prospective cohort study with Argus II System. Several controls are   show the rest ...
Study Population Description Age 25 years or older; both males and females; with severe to profound retinitis pigmentosa;   show the rest ...
Sample Size A total of 53 subjects will be enrolled in the study. It is anticipated that   show the rest ...
Data Collection Primary: Safety (i.e. adverse event rates), with the main safety analysis performed when all subjects   show the rest ...
Followup Visits and Length of Followup 5 years

Baseline, implant, month 1, 3, 6, 12, 24, 36, 48, 60.

Various follow-up assessments including   show the rest ...

OSB Lead-New Enrollment Argus II Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 08/14/2013 08/14/2013 On Time
one year report 02/13/2014 02/11/2014 On Time
18 month report 08/14/2014 08/18/2014 Overdue/Received
two year report 02/13/2015 02/13/2015 On Time
three year report 02/13/2016 02/16/2016 Overdue/Received
four year report 02/12/2017    
five year report 02/12/2018    

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