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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 09/03/2014
Study Name OSB Lead-Durability II PAS
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 Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The PAS is a prospective, multi‐center, non‐randomized, single arm study with sequential enrollment of all   show the rest ...
Study Population Description Adult patients with lesions no greater than 180 mm in length in the native superficial   show the rest ...
Sample Size The sample size of 113 is driven by the need for the above noted precision   show the rest ...
Data Collection Primary endpoints

A composite endpoint defined as freedom from acute death, freedom from 36‐month amputation, and   show the rest ...
Followup Visits and Length of Followup Follow‐up visits will occur pre‐discharge, at one month, at one year, and annually thereafter, up   show the rest ...

OSB Lead-Durability II PAS 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 03/05/2013 On Time
18 month report 09/05/2013 09/04/2013 On Time
two year report 03/07/2014 03/04/2014 On Time
three year report 03/07/2015 02/27/2015 On Time
four year report 03/06/2016 03/02/2016 On Time
five year report 03/06/2017    

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