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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 Adjunct
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 Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective study cohort to continue the follow-up of premarket cohort to evaluate   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 Between study start in 1998 and device approval in November 2006, there were 43,384 reconstruction   show the rest ...
Data Collection Primary objectives are to evaluated and estimate the rates of local complications (for example, capsular   show the rest ...
Followup Visits and Length of Followup There are 3 scheduled follow up visits at 1, 3 and 5 years. Length of follow up is 5 years.
Final Study Results
Actual Number of Patients Enrolled A total of 84, 329 patients were enrolled in the study; 45,055 in the reconstruction   show the rest ...
Actual Number of Sites Enrolled 2,696 sites
Patient Followup Rate Reconstruction cohort: 54.3% at Year 1, 29.8% at Year 3, 17.8% at Year 5

Revision cohort:   show the rest ...
Final Safety Findings The most commonly observed complications in the reconstruction and revision cohorts were capsular contracture, asymmetry,   show the rest ...
Final Effectiveness Findings For the reconstruction cohort, on a 1 (definitely dissatisfied) to 5 (definitely satisfied) scale, the   show the rest ...
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. The Adjunct Study was designed to address the public health needs of reconstruction and   show the rest ...


Adjunct Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year adjunct study report 11/17/2007 11/16/2007 On Time
Annual PAS report 02/27/2008 02/27/2008 On Time
2007 Annual report 02/27/2008 02/27/2008 On Time
2 year report 11/16/2008 10/16/2008 On Time
3 year report 11/16/2009 11/12/2009 On Time
4 year report 11/16/2010 11/15/2010 On Time
5 year report 11/16/2011 11/04/2011 On Time
Final Report 02/17/2013 02/11/2013 On Time

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