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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 P040025
Current Protocol Accepted 12/20/2006
Study Name VON Registry
Study Status Completed
General Study Protocol Parameters
Study Design Active Surveillance
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs
Detailed Study Protocol Parameters
Study Design Description This is a prospective observational study, using the Vermont Oxford Network (VON) Registry, Burlington, Vermont:   show the rest ...
Study Population Description Study population is as per device indication. The device is indicated for use in fullterm   show the rest ...
Sample Size No sample size or power calculations are provided in the protocol.The sponsor expects that participation   show the rest ...
Data Collection Data to be collected on infants treated with the Cool-Cap will include the following information.   show the rest ...
Followup Visits and Length of Followup The sponsor will discontinue participation in the registry, and reporting of data, after 5 years.
Final Study Results
Actual Number of Patients Enrolled 551
Actual Number of Sites Enrolled 16
Patient Followup Rate 100%
Final Safety Findings Infants in the current registry had higher rates of adverse events including minor cardiac arrhythmias,   show the rest ...
Final Effectiveness Findings Effectiveness findings were not reported.
Study Strengths and Weaknesses Although important data was collected about patient characteristics and adverse events for these infants during   show the rest ...
Recommendations for Labeling Changes The sponsor was asked to update their labeling to reflect the changes in clinical practice   show the rest ...

VON Registry Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
1 year report 12/20/2007 12/20/2007 On Time
2 year report 12/19/2008 12/17/2008 On Time
3 year report 12/19/2009 12/16/2009 On Time
4 year report 12/19/2010 12/16/2010 On Time
5 year report 12/19/2011 12/14/2011 On Time
6 year report-final report 12/19/2012 11/02/2012 On Time

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