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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 P070001
Most Recent Protocol Version Approved 08/12/2008
Study Name Enhanced Surveillance Study
Study Status Completed
General Study Protocol Parameters
Study Design Enhanced Surveillance
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an enhanced surveillance system to collect the patietns demographic, clinical and device information   show the rest ...
Study Population Description Study population is as per device approval. The study includes all patients who received Prodisc   show the rest ...
Sample Size n/a
Data Collection Complaints and Adverse events
Followup Visits and Length of Followup up to 5-year after device approval
Final Study Results
Actual Number of Patients Enrolled Not applicable this is Enhanced surveillance investigation
Actual Number of Sites Enrolled Not applicable this is Enhanced surveillance investigation
Patient Followup Rate Not applicable this is Enhanced surveillance investigation
Final Safety Findings Since the PMA approval of December 17, 2007 through November 1, 2012,

theinformation on the cumulative   show the rest ...
Final Effectiveness Findings Not applicable this is Enhanced surveillance investigation
Study Strengths and Weaknesses The duration of the Enhanced Surveillance System was 5 years after PMA approval, allowing time   show the rest ...
Recommendations for Labeling Changes No labeling change is recommended because the adverse events noted in the final report are   show the rest ...


Enhanced Surveillance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 06/16/2008 06/18/2008 Overdue/Received
1 year report 12/16/2008 12/17/2008 Overdue/Received
18 month report 06/16/2009 06/18/2009 Overdue/Received
2 year report 12/16/2009 12/31/2009 Overdue/Received
3 year report 12/16/2010 12/20/2010 Overdue/Received
4 year report 12/16/2011 12/14/2011 On Time
5 year report-final report 12/15/2012 12/14/2012 On Time

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