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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 P010012 S230
Most Recent Protocol Version Approved 09/27/2011
Study Name MADIT-CRT Registry
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Final Study Results
Actual Number of Patients Enrolled 394 patients
Actual Number of Sites Enrolled 49 centers
Patient Followup Rate 98.98% (390/394)
Final Safety Findings The rate of device system related adverse events (number of Events/100 Device Months) is slightly   show the rest ...
Final Effectiveness Findings The cohort of combined IDE and Registry for followed out through 5 years showed CRT-D   show the rest ...
Study Strengths and Weaknesses Strength: long-term follow-up (5 years)

Weakness: small sample size (394 patients) insufficient to test statistical significance   show the rest ...
Recommendations for Labeling Changes NO


MADIT-CRT Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 03/17/2011 03/16/2011 On Time
one year report 09/16/2011 09/14/2011 On Time
18 month report 03/16/2012 03/15/2012 On Time
two year report 09/16/2012 09/17/2012 Overdue/Received
30 month report 03/16/2013 03/14/2013 On Time
three year report-final report 10/31/2013 10/30/2013 On Time

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