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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 P120010
Most Recent Protocol Version Approved 09/26/2013
Study Name PAS of TS Feature w/a Sensor-Augmented Pump System
Study Status Progress Inadequate
Study Progress Reason Site enrollment milestones not met, Subject enrollment milestones not met
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description A longitudinal, multi-center study to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin   show the rest ...
Study Population Description Adult (16 years and older) US subjects that meet the inclusion/exclusion criteria. Subjects will be   show the rest ...
Sample Size Investigational centers (50 sites) will be selected across the United States. Up to 1,200 subjects   show the rest ...
Data Collection Primary endpoint: The overall mean change in A1C from baseline will be estimated and compared   show the rest ...
Followup Visits and Length of Followup 12 months after enrollment.



Each patient will be followed-up in 5 visits in the 12-month period,   show the rest ...


PAS of TS Feature w/a Sensor-Augmented Pump System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
four month report 03/27/2014 01/26/2014 On Time
eight month report 06/13/2014 06/13/2014 On Time
one year report 09/26/2014    
18 month report 03/27/2015    
two year report 09/26/2015    
three year report 09/25/2016    
four year report 09/25/2017    
five year report 09/25/2018    

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