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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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P080013
Current Protocol Accepted 02/03/2016
Study Name OSB Lead-DuraSeal Exact Spine Sealant System
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective: Estimate the rates of post-operative CSF leak, deep surgical site infection and neurological SAEs   show the rest ...
Study Population Description For the retrospective controls (standard of care), subjects with fewer than 45 days of follow-up   show the rest ...
Sample Size The DuraSeal Exact Spine Sealant prospective treatment arm will enroll up to 489 subjects in   show the rest ...
Data Collection The primary endpoint is the occurrence of post-operative CSF leaks within 90 days after the   show the rest ...
Followup Visits and Length of Followup For retrospective controls (standard of care), a patient will be considered completed if there is   show the rest ...


OSB Lead-DuraSeal Exact Spine Sealant System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month interim report 07/06/2010 07/06/2010 On Time
1 year report 09/04/2010 11/12/2010 Overdue/Received
2 year report 09/04/2011 09/21/2011 Overdue/Received
6 month report 03/04/2012 03/02/2012 On Time
3 year report 09/03/2012 10/01/2012 Overdue/Received
4 year report 09/03/2013 09/19/2013 Overdue/Received
5 year report 09/03/2014 09/02/2014 On Time
6 year report 09/03/2015 08/20/2015 On Time
7 year report/final report 10/31/2016    

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