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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 P080030
Most Recent Protocol Version Approved 03/08/2013
Study Name 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 Prospective, randomized, concurrently controlled, parallel group, multicenter investigation

Surgery consisting of implantation of one (1) GTS100   show the rest ...
Study Population Description Males or Females, 22 years of age or older

Inclusion and exclusion criteria are consistent with   show the rest ...
Sample Size With estimated rates of 0.03 (3%) for PT and Pc at 5 years, a Type   show the rest ...
Data Collection The primary endpoints will be the occurrence of sight-threatening adverse

events. The sight threatening adverse events   show the rest ...
Followup Visits and Length of Followup Frequency of Follow-up

Assessments the examination schedule is as follows:

Visit 1 - Screening (day -60 to day   show the rest ...


New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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    
three year report 06/25/2015    
four year report 06/24/2016    
five year report 06/24/2017    

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