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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 P060017
Current Protocol Accepted 10/29/2007
Study Name TS Study
Study Status Other
Study Progress Reason Device not marketed
General Study Protocol Parameters
Study Design Cross-Sectional 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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The post-approval study is designed to address the following objectives: 1) to determine, under clinical   show the rest ...
Study Population Description Study Population: Breast cancer patients. Indication: The device is indicated as an in vitro diagnostic   show the rest ...
Sample Size 320 patients, 4 sites
Data Collection Assay turn-around-time data was collected on each eligible patient from the time the sentinel lymph   show the rest ...
Followup Visits and Length of Followup Follow-up was not required for this study.


TS Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report TS Study 01/14/2008 01/11/2008 On Time
1 year report TS Study 07/15/2008 07/11/2008 On Time
21 month progress report 04/20/2009 04/20/2009 On Time
Resp R8 RDEF & 24 month report 07/19/2009 07/21/2009 Overdue/Received
27 month report 10/15/2009 10/13/2009 On Time
Final Report 01/13/2010 04/30/2010 Overdue/Received

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