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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 P080009
Most Recent Protocol Version Approved 03/29/2013
Study Name Open Label PAS of the SEDASYS System User Response
Study Status Other
Study Progress Reason Device not marketed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a single arm, non-randomized, non-blinded, multi-center, prospective, study of sedation during colonoscopy   show the rest ...
Study Population Description Up to 32 users in up to 15 sites with diversity through multiple US regions   show the rest ...
Sample Size A sample size of 840 would be appropriate for this study. Accounting for a 3%   show the rest ...
Data Collection The primary endpoint will be the percentage of documented responses to alarms.

Secondary Endpoint:

The secondary endpoint   show the rest ...
Followup Visits and Length of Followup Subject data will be collected prior to and during use of SEDASYS System through discharge.   show the rest ...


Open Label PAS of the SEDASYS System User Response Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 11/01/2013 12/16/2013 Overdue/Received
one year report 05/03/2014 05/02/2014 On Time
18 month report 11/01/2014    
two year report 05/03/2015    
three year report 05/02/2016    
four year report 05/02/2017    
five year report 05/02/2018    

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