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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
Most Recent Protocol Version Approved 02/06/2014
Study Name DuraSeal Exact Spine Sealant System
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met
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 Subjects who undergo a spinal procedure where DuraSeal¿ Exact Spine Sealant (DuraSeal¿ Sealant arm only)   show the rest ...
Sample Size A total of 884 subjects need be enrolled. Both treatment arms will enroll up to   show the rest ...
Data Collection The primary endpoint is the occurrence of post-operative CSF

leaks within 90 days after the spine   show the rest ...
Followup Visits and Length of Followup 90 days after treatment

90 days after treatment (± 30 days)


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    

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