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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 P030053
Most Recent Protocol Version Approved 11/17/2006
Study Name Core
Study Status Completed
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 Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Core study is a 10-year prospective, open-label, multi-center cohort study to evaluate the safety   show the rest ...
Study Population Description The study populaiton is as per device indication. This device is indicated for breast augmentation   show the rest ...
Sample Size 1000 patients at up to 40 sites
Data Collection Safety endpoints include point prevalence on a per patient and per device basis of rates   show the rest ...
Followup Visits and Length of Followup 11 follow-up visits (6 months and annually 1-10 years after surgery) during 10 years of study
Final Study Results
Actual Number of Patients Enrolled 1,008
Actual Number of Sites Enrolled 48
Patient Followup Rate 62% at 10 years
Final Safety Findings For the Primary Augmentation cohort, the 10-year Kaplan-Meier estimated cumulative incidence rates for the key   show the rest ...
Final Effectiveness Findings The overall mean changes in circumferential chest size were positive and statistically significant. The overall   show the rest ...
Study Strengths and Weaknesses One of the study strengths is that the study is a prospective, multicenter study that   show the rest ...
Recommendations for Labeling Changes The labeling will be updated based on the 10-year safety and effectiveness results reported in   show the rest ...


Core Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
CORE 1 year Study Report 11/17/2007 11/16/2007 On Time
CORE 2 Year Study Report 11/16/2008 11/17/2008 Overdue/Received
CORE 3 Year Study Report 12/11/2009 12/14/2009 Overdue/Received
CORE 4 Year Study Report 11/16/2010 11/16/2010 On Time
CORE 5 Year Study Report 11/16/2011 11/17/2011 On Time
CORE 6 Year Study Report - FINAL 11/13/2012 11/13/2012 On Time

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