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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 P020056
Current Protocol Accepted 10/01/2012
Study Name BIFS (Large PAS)
Study Status Progress Inadequate
Study Progress Reason Follow-up rate below 80%
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 Concurrent Control
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 The large PAS is a 10-year multi-center, prospective cohort study designed to compare targeted safety   show the rest ...
Study Population Description The study population is as per device indication. This device is indicated for breast augmentation   show the rest ...
Sample Size The study will enroll 54,630 female subjects who elect to receive unilateral or bilateral breast   show the rest ...
Data Collection 1. The long-term safety profile of silicone breast implants, especially as it relates to connective   show the rest ...
Followup Visits and Length of Followup There are 4 follow up clinic visits at 1 wk post surgery, 1 year, 4   show the rest ...


BIFS (Large PAS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Large PAS 3 month report 02/16/2007 03/09/2007 Overdue/Received
Large PAS 6 month report 05/18/2007 05/16/2007 On Time
Large PAS 9 month report 08/17/2007 08/16/2007 On Time
Large PAS 1 year report 11/17/2007 11/13/2007 On Time
Large PAS 15 month report 02/16/2008 02/12/2008 On Time
Large PAS 18 month report 05/17/2008 05/08/2008 On Time
Large PAS 21 month report 08/16/2008 08/13/2008 On Time
Protocol Deviations report 10/24/2008 10/24/2008 On Time
Large PAS 2 year report 11/16/2008 11/12/2008 On Time
Large PAS 27 month report 02/15/2009 02/13/2009 On Time
Large PAS 30 month report 05/17/2009 05/15/2009 On Time
Large PAS 33 month report 08/16/2009 08/14/2009 On Time
Large PAS 3 year report 11/16/2009 11/10/2009 On Time
Large PAS 39 month report 02/15/2010 02/12/2010 On Time
Large PAS 42 month report 05/17/2010 05/13/2010 On Time
Large PAS 45 month report 08/16/2010 08/11/2010 On Time
Large PAS 4 year report 11/16/2010 11/12/2010 On Time
Large PAS 51 month report 02/15/2011 02/11/2011 On Time
Large PAS 54 month report 05/17/2011 05/12/2011 On Time
Large PAS 57 month report 08/16/2011 08/15/2011 On Time
Large PAS 5 year report 11/16/2011 11/17/2011 Overdue/Received
Large PAS 63 month report 02/15/2012 02/10/2012 On Time
Large PAS 66 month report 05/16/2012 05/14/2012 On Time
Large PAS 69 month report 08/15/2012 08/09/2012 On Time
Large PAS 6 year report 11/19/2012 11/27/2012 On Time
Large PAS 7 year report 11/15/2013 11/14/2013 On Time
Large PAS 8 year report 11/15/2014 11/06/2014 On Time
Large PAS 9 year report 11/15/2015    
Large PAS 10 year report 11/14/2016    

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