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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 P070004
Current Protocol Accepted 05/29/2012
Study Name Post-Approval PMA Cohorts Study (PACS)
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
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 PMA Cohorts Study (PACS) will continue to follow subjects from premarket cohorts for   show the rest ...
Study Population Description Women who received Sientra¿s silicone breast implants and were enrolled in the premarket Core Study   show the rest ...
Sample Size A total of 1,788 subjects have been enrolled in Sientra¿s PACS at 33 sites throughout   show the rest ...
Data Collection The safety endpoints include local complications, implant rupture, connective tissue diseases (CTDs), CTD signs and   show the rest ...
Followup Visits and Length of Followup 10 years

Annually



Post-Approval PMA Cohorts Study (PACS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 09/07/2012 09/07/2012 On Time
one year report 03/09/2013 03/12/2013 Overdue/Received
two year report 03/09/2014 03/07/2014 On Time
three year report 03/09/2015    
four year report 03/08/2016    
five year report 03/08/2017    
Final Report 03/09/2018    

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