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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 P060040
Current Protocol Accepted 04/21/2008
Study Name INTERMACS Registry
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The proposed study is a prospective non-randomized observational study, with subjects obtained from the INTERMACS   show the rest ...
Study Population Description All patients who are identified pre-implant in the INTERMACS database as "Bridge to Transplant (patient   show the rest ...
Sample Size 169 HeartMate patients and 169 controls from the INTERMACS Registry
Data Collection Endpoints include: 1) procedural success, 2) incidence of adverse events. Bleeding adverse events will include   show the rest ...
Followup Visits and Length of Followup All subjects and controls will be assessed at one week, one month, 3 months, 6   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 338
Actual Number of Sites Enrolled 77
Patient Followup Rate 99
Final Safety Findings The most common adverse events overall were bleeding, infection, cardiac arrhythmia, and respiratory failure. Compared   show the rest ...
Final Effectiveness Findings Success was defined as LVAS support for at least 180 days or to transplant, or   show the rest ...
Study Strengths and Weaknesses Strengths: Follow-up rate was very high (99%); all subjects were prospectively followed; a concurrent control   show the rest ...
Recommendations for Labeling Changes Labeling changes should be accomplished in accordance with the findings of the PAS.


INTERMACS Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 10/20/2008 10/15/2008 On Time
1 year report 04/21/2009 04/20/2009 On Time
18 month report 10/20/2009 10/20/2009 On Time
2 year report 04/21/2010 04/13/2010 On Time
Final Report 04/21/2011 04/15/2011 On Time

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