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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 P110039
Current Protocol Accepted 03/15/2013
Study Name OSB Lead-New Enrollment 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 No Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is multi-center prospective cohort. .
Study Population Description The sample size is 70 patients. Sample size and power calculations are provided in the   show the rest ...
Sample Size The sample size is 70 patients. Sample size and power calculations are provided in the   show the rest ...
Data Collection Study endpoints include pain response, medication use and quality of life.
Followup Visits and Length of Followup Patients will undergo clinical examination at the time of enrollment and one month and 3   show the rest ...

OSB Lead-New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 04/18/2013 06/18/2013 Overdue/Received
one year report 10/18/2013 10/28/2013 Overdue/Received
18 month report 04/18/2014 05/07/2014 Overdue/Received
two year report 10/18/2014 11/05/2014 Overdue/Received
three year report 10/18/2015 11/06/2015 Overdue/Received
four year report 10/17/2016    
five year report 10/17/2017    

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