• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies

  • Print
  • Share
  • E-mail
-

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

Show All Studies
Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
General
Application Number P890055 S026
Current Protocol Accepted 03/15/2011
Study Name Long-Term Surveillance of MedStream
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 Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, single arm, multi-center study with consecutive enrollment.



The null hypothesis for   show the rest ...
Study Population Description The study population included patients presenting for de novo implant or replacement of an implantable   show the rest ...
Sample Size Subjects will be enrolled in the study to account for loss to follow-up and for   show the rest ...
Data Collection

The primary endpoint is based on Clinical Events Committee determination of relationship.



  show the rest ...
Followup Visits and Length of Followup All subjects are to be followed for a few months and are required to have   show the rest ...


Long-Term Surveillance of MedStream Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 06/17/2011 06/16/2011 On Time
one year report 12/17/2011 12/15/2011 On Time
18 month report 06/16/2012 06/15/2012 On Time
two year report 12/16/2012 12/17/2012 Overdue/Received
30 month report 06/16/2013 06/20/2013 Overdue/Received
three year report 12/16/2013 12/16/2013 On Time
39 month report 05/14/2014 05/14/2014 On Time
four year report 12/16/2014    
five year report 12/16/2015    
six year report 12/15/2016    

Show All Studies

-
-