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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 P110009
Current Protocol Accepted 05/08/2014
Study Name OSB Lead-Long Term PAS
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 Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objective of the study is to evaluate the long-term

overall success rate (see primary   show the rest ...
Study Population Description All eligible Mobi-C patients (n=221 -randomized and n=8 - training cases) treated at two contiguous   show the rest ...
Sample Size Investigational¿n=221 -randomized and n=8 -training cases at treated at two contiguous levels. Control¿ all eligible   show the rest ...
Data Collection For Mobi-C: Pain/Disability Improvement of at least 25% in the Neck Disability Index (NDI) at   show the rest ...
Followup Visits and Length of Followup 7 years at 7th year

OSB Lead-Long Term PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 02/21/2014 02/21/2014 On Time
one year report 08/23/2014 08/21/2014 On Time
18 month report 02/21/2015 02/23/2015 Overdue/Received
two year report 08/23/2015 08/20/2015 On Time
Final Report 05/27/2016 05/31/2016 Overdue/Received

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