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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 P040034
Current Protocol Accepted 04/07/2005
Study Name Duraseal
Study Status Completed
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 The PAS is a prospective, randomized, single-blinded (patients), multi-center study to further characterize the DuraSeal   show the rest ...
Study Population Description This device is indicated for use as an adjunct to sutured dural repair during cranial   show the rest ...
Sample Size 250 patients; approximately 25 centers
Data Collection The primary outcome is the incidence of neurosurgical complications related to unplanned intervention (i.e., minimally   show the rest ...
Followup Visits and Length of Followup Patients are followed for 30 days after treatment, and are evaluated clinically at discharge and   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 237 patients
Actual Number of Sites Enrolled 17 centers
Patient Followup Rate 98.30%
Final Safety Findings There were 18 primary endpoint complications in 16 subjects: 9 happened in 8 patients in   show the rest ...
Study Strengths and Weaknesses High follow up rate. Randomized design.
Recommendations for Labeling Changes The sponsor updated the labeling to reflect the post-approval study results prior to FDA completing   show the rest ...


Duraseal Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 10/06/2005 10/11/2005 Overdue/Received
1 year report 04/07/2006 04/06/2006 On Time
18 month report 10/06/2006 10/13/2006 Overdue/Received
2 year report 04/07/2007 04/09/2007 Overdue/Received
30 month report 12/12/2007 12/12/2007 On Time
3 year report 04/06/2008 04/08/2008 Overdue/Received
4 year report 04/06/2009 04/07/2009 Overdue/Received
5 year report 04/06/2010 12/23/2009 On Time

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