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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 P130017
Current Protocol Accepted 02/02/2015
Study Name Cologuard PAS
Study Status Progress Adequate
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 Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study objective is to collect longitudinal data on subjects for whom Cologuard is used   show the rest ...
Study Population Description The study population is defined with the following criteria: Subjects must meet the following criteria   show the rest ...
Sample Size A total of 2,173 subjects will be enrolled to have 1,119 subjects at the year   show the rest ...
Data Collection The primary endpoint for this study is the difference between the positive predictive value (PPV)   show the rest ...
Followup Visits and Length of Followup Study participants will be followed for 3 years


Cologuard PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 02/09/2015 02/24/2015 Overdue/Received
one year report 08/11/2015 08/07/2015 On Time
18 month report 02/09/2016    
two year report 08/10/2016    
three year report 08/10/2017    
four year report 08/10/2018    
five year report 08/10/2019    

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