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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 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 This study is a 10-year followup of the Core Clinical Study with the objecitve to   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 940 participants, 46 sites.
Data Collection Effectiveness endpoints are circumferential chest size change, bra cup size change (augmentation patients only), patient   show the rest ...
Followup Visits and Length of Followup Patients were to be followed for 10 years. Patient follow-up is at 6 months, 1   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 715 patients including 455 primary augmentation, 147 revision-augmentation, 98 primary-reconstruction and 15 revision-reconstruction patients.   show the rest ...
Actual Number of Sites Enrolled 23
Patient Followup Rate The follow-up rates for each cohort varied, but the overall rate was above 65% at   show the rest ...
Final Safety Findings The most commonly reported complications for all cohorts include capsular contracture, breast pain, swelling, symmetry,   show the rest ...
Final Effectiveness Findings Majority of the patients and physicians were satisfied with the surgical outcome. In the augmentation   show the rest ...
Study Strengths and Weaknesses One of the study strength 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 safety and effectiveness results reported in the   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 Report 11/16/2008 11/14/2008 On Time
CORE 3 year Report 11/16/2009 11/16/2009 On Time
CORE 4 year Report 11/16/2010 11/12/2010 On Time
CORE 5 year Report & Final Report 11/16/2011 08/26/2011 On Time
response to R43 RDEF & Final Report 03/17/2012 03/15/2012 On Time

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