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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 P100026
Most Recent Protocol Version Approved 09/03/2014
Study Name New Enrollment - Performance & Programming
Study Status Study Pending
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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an open label, prospective, observational study of performance and programming of the RNS   show the rest ...
Study Population Description Subjects implanted with the RNS System who are 18 years of age

or older with partial   show the rest ...
Sample Size A total of 375 subjects may be enrolled in order to have for

evaluation a minimum   show the rest ...
Data Collection Part 1: Performance

1.1 Severe adverse event rate within sub-populations

1.2 Median percentage reduction in seizures within   show the rest ...
Followup Visits and Length of Followup

5 years

The study consists of 3 time periods (a) pre-implant, including enrollment and initial clinical   show the rest ...

New Enrollment - Performance & Programming Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 05/15/2014 05/08/2014 On Time
one year report 11/14/2014    
18 month report 05/15/2015    
two year report 11/14/2015    
three year report 11/13/2016    
four year report 11/13/2017    
five year report 11/13/2018    

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