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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 P110014
Current Protocol Accepted 04/29/2014
Study Name OSB Lead-MarginProbe System US PAS
Study Status Progress Inadequate
Study Progress Reason Site enrollment milestones not met, Subject enrollment milestones not met
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) No
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 This is a prospective, newly enrolled, multicenter, randomized, double arm, controlled study of adjunctive use   show the rest ...
Study Population Description Women histologically diagnosed with carcinoma of the breast

and women with non-palpable malignant lesions, requiring image   show the rest ...
Sample Size A total of 440 subjects with 220 in each arm.
Data Collection Co - Primary effectiveness endpoints are:

a. Sensitivity at the margin level b. Specificity at the   show the rest ...
Followup Visits and Length of Followup Patients will be followed until evaluation of cosmetic status, performed at 6 +/- 1 month   show the rest ...

OSB Lead-MarginProbe System US PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 06/27/2013 06/26/2013 On Time
one year report 12/27/2013 12/23/2013 On Time
18 month report 06/27/2014 06/27/2014 On Time
two year report 12/27/2014 12/24/2014 On Time
three year report 12/27/2015 12/24/2015 On Time
42 month report 06/27/2016 06/27/2016 On Time
four year report 12/26/2016    
five year report 12/26/2017    

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