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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 P040040
Current Protocol Accepted 09/07/2007
Study Name OSB Lead-5 year long term (IDE)
Study Status Terminated
Study Progress Reason Other reason
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study will provide long-term follow-up of forty-three subjects from the premarket cohort that have   show the rest ...
Study Population Description This device is indicated for use in patients with a complex VSD of significant size   show the rest ...
Sample Size 43 patients, 21 sites
Data Collection Safety endpoints include adverse events.
Followup Visits and Length of Followup Annual office visits were required out to 5 years.
Final Study Results
Actual Number of Patients Enrolled 43
Actual Number of Sites Enrolled 38
Patient Followup Rate 24%
Final Safety Findings A total of 35 overall events were reported in 20 of 43 subjects (46.5%). The   show the rest ...
Study Strengths and Weaknesses Strengths: Lessons learned on requesting for long term follow-up consent at tiem of IDE enrollment

Weaknesses:   show the rest ...
Recommendations for Labeling Changes No labeling changes were recommended.

OSB Lead-5 year long term (IDE) Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 03/07/2008 03/05/2008 On Time
1 year report 09/07/2008 09/08/2008 Overdue/Received
18 Month Report 03/05/2009 03/05/2009 On Time
2 year report 09/07/2009 10/15/2009 Overdue

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