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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 P110023
Current Protocol Accepted 03/07/2012
Study Name OSB Lead-Cont FU of Premarket Cohort
Study Status Completed
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 Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Final Study Results
Actual Number of Patients Enrolled 287
Actual Number of Sites Enrolled 51
Patient Followup Rate 86%
Final Safety Findings Stent fracture rate at 3 years:0.9%

(Other key safety endpoints are subsumed in primary effectiveness endpoint   show the rest ...
Final Effectiveness Findings CDTLR at 3 years: 30%

Major amputation rate at 3 years: 0.8% Death rate at 30   show the rest ...
Study Strengths and Weaknesses The main study limitations derive from the fact that the study population consisted of subjects   show the rest ...
Recommendations for Labeling Changes yes

OSB Lead-Cont FU of Premarket Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 09/05/2012 08/24/2012 On Time
one year report 03/07/2013 02/26/2013 On Time
18 month report-final report 09/05/2013 10/02/2013 Overdue/Received

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