• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies

  • Print
  • Share
  • E-mail

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

Show All Studies
Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
Application Number H080002
Current Protocol Accepted 09/24/2013
Study Name Generalizability Study
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 Objective Performance Criterion
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, observational, non-randomized, multi-center study. The study purpose is to confirm the   show the rest ...
Study Population Description Consecutive subjects at each site will be invited to participate in the study if they   show the rest ...
Sample Size 100 patients, 10-15 sites
Data Collection The primary endpoint is the percentage of subjects with acceptable hemodynamic function at six months   show the rest ...
Followup Visits and Length of Followup Follow-up of the clinical endpoints will be conducted at baseline (pre-implant), discharge from the hospital,   show the rest ...

Generalizability Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 07/26/2010 07/19/2010 On Time
1 year report 01/25/2011 01/26/2011 Overdue/Received
18 month report 07/26/2011 07/26/2011 On Time
2 year report 01/25/2012 01/25/2012 On Time
request to move reporting dates 07/11/2012 07/11/2012 On Time
30 month report 07/25/2012 07/25/2012 On Time
3 year report 07/26/2013 07/26/2013 On Time
4 year report 07/26/2014 07/24/2014 On Time
5 year report 07/26/2015   Overdue

Show All Studies