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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 P130016
Current Protocol Accepted 09/11/2014
Study Name Extended f/u study
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an extended follow-up of the premarket cohort. The purpose of the study is   show the rest ...
Study Population Description Subjects from the original pivotal study and

associated Continued Access study who remain implanted with Hybrid   show the rest ...
Sample Size Up to 35 subjects.
Data Collection The primary safety endpoint will be the comparison of the type

and frequency of adverse events   show the rest ...
Followup Visits and Length of Followup 5 years post-activation for each subject

2 years post-activation (if not yet completed), 3 years post-   show the rest ...


Extended f/u study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 09/18/2014 09/19/2014 Overdue/Received
one year report 03/20/2015    
18 month report 09/18/2015    
two year report 03/19/2016    
three year report 03/19/2017    
four year report 03/19/2018    
five year report 03/19/2019    

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