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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 Adjunct Study
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 Adjunct study is a 5-year study, in which patients will be followed at 1,   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 number of study sites: 2,958; 12,811 reconstruction patients were implanted with 23,090 implants
Data Collection Safety endpoints include clinical complications such as infection, seroma, implant rupture and capsular contracture at   show the rest ...
Followup Visits and Length of Followup 3 follow-up visits during 5 years of study (1, 3, 5 years post-implantation)
Final Study Results
Actual Number of Patients Enrolled 147,585
Actual Number of Sites Enrolled 4,684
Patient Followup Rate 44.0% at 1 year, 24.7% at 3 years, 13.8% at 5 years
Final Safety Findings The 3 most commonly reported complications using the Kaplan-Meier cumulative incidence estimates at

5 years were:   show the rest ...
Final Effectiveness Findings N/A
Study Strengths and Weaknesses A large number of patients were enrolled in the adjunct study. However, the study was   show the rest ...
Recommendations for Labeling Changes No


Adjunct Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
2 year report 11/16/2008 11/12/2008 On Time
3 year report 11/16/2009 11/12/2009 On Time
4 year report 11/16/2010 11/04/2010 On Time
5 year report 11/16/2011 11/04/2011 On Time
final report 11/02/2012 11/02/2012 On Time

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