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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
Current Protocol Accepted 06/30/2015
Study Name OSB Lead-New Enrollment - All Comers
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met, Follow-up rate below 80%, More than 10% of the primary endpoint data missing
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 Objectives

The primary safety objective is to characterize the annual serious adverse event (SAE) rate over   show the rest ...
Study Population Description The study population will consist of individuals 18 years of age or older with partial   show the rest ...
Sample Size Up to 375 subjects may be enrolled from up to 30 sites in order that   show the rest ...
Data Collection Primary Safety Endpoint: Severe adverse event rate; Secondary Safety Endpoints: Seizure worsening

Primary effectiveness endpoint: Median   show the rest ...
Followup Visits and Length of Followup Enrollment plan: 2 patients every other month after the first site is enrolled, 12 patients   show the rest ...

OSB Lead-New Enrollment - All Comers Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 05/15/2014 05/07/2014 On Time
one year report 11/14/2014 11/12/2014 On Time
18 month report 05/15/2015 05/07/2015 On Time
two year report 11/14/2015 10/21/2015 On Time
30 month report 05/14/2016 05/13/2016 On Time
three year report 11/13/2016    
four year report 11/13/2017    
five year report 11/13/2018    

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