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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 P130008
Current Protocol Accepted 04/30/2014
Study Name Extended F/U Premarket Cohort Inspire 4 STAR Trial
Study Status Study Pending
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description to demonstrate long-term safety - Prospective, single arm cohort study
Study Population Description Subjects implanted with the Inspire UAS System under the premarket study.
Sample Size Approximately 124 STAR trial subjects are available for the

extended follow-up

Data Collection Long term safety of the Inspire system will be assessed via the description of all   show the rest ...
Followup Visits and Length of Followup 5 years post-implant


Extended F/U Premarket Cohort Inspire 4 STAR Trial Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
one yea report 04/30/2015    
two year report 04/29/2016    
three year report 04/29/2017    
Final Report 06/29/2017    

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