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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 03/05/2013
Study Name OSB Lead-Extended F/u of IDE Cohort Study
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Extended follow-up of subjects previously enrolled in Glaukos Study

GC-003; Follow-up through 5 years postoperative

  show the rest ...
Study Population Description ¿ Inclusion Criteria: Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to   show the rest ...
Sample Size Of 290 subjects enrolled in Study GC-003, extended follow-up is

planned on subjects eligible to participate   show the rest ...
Data Collection The safety measurement listed in the outline section as:

¿ Postoperative ocular adverse events

¿ Findings from OR medication   show the rest ...
Followup Visits and Length of Followup 5 years postoperative. 2 years from completion of the IDE study


Final Study Results
Actual Number of Patients Enrolled 108
Actual Number of Sites Enrolled 25
Patient Followup Rate Only 42.35% (108/255) enrolled at the beginning of the IDE cohort continuation study. Of those   show the rest ...
Final Safety Findings Kaplan-Meier (K-M) analyses for the sight-threatening adverse event rate at 5 years are provided by   show the rest ...
Final Effectiveness Findings This study does not include any effectiveness endpoints
Study Strengths and Weaknesses Strength: The continued IDE study is an observational study with a clinical trial design with   show the rest ...
Recommendations for Labeling Changes As a result, upon completion of the post approval studies with significant clinical findings, labeling   show the rest ...

OSB Lead-Extended F/u of IDE Cohort 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-Final Report 06/25/2014 05/01/2014 On Time
response to R11 RDEF (final report) 09/29/2014 09/29/2014 On Time

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