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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 P030054 S173
Current Protocol Accepted 03/02/2012
Study Name OSB Lead-QUAD 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 Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective multi-center study
Study Population Description Patients can be approached in one of two ways for enrollment:

¿ Through patient participation in the   show the rest ...
Sample Size 1,884 new patients will be enrolled to achieve an evaluable sample size of 1,036 patients.   show the rest ...
Data Collection Primary endpoints: to estimate:

¿ Freedom from system-related complications through 5 years.

¿ Freedom from system-related complications through 5   show the rest ...
Followup Visits and Length of Followup All patients will have a total duration of follow-up of 5 years from the

date of   show the rest ...

OSB Lead-QUAD PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 05/29/2012 05/29/2012 On Time
one year report 11/28/2012 12/03/2012 Overdue/Received
18 month report 05/29/2013 05/29/2013 On Time
unsolicited report 11/25/2013 11/25/2013 On Time
two year report 11/28/2013 11/26/2013 On Time
rqst to change reporting 02/28/2014 02/28/2014 On Time
30 month report 05/29/2014 05/23/2014 On Time
three year report 11/28/2014 12/08/2014 Overdue/Received
42 month report 05/29/2015 06/01/2015 Overdue/Received
four year report 11/28/2015 12/01/2015 Overdue/Received
54 month report 05/28/2016 06/01/2016 Overdue/Received
five year report 11/27/2016    

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