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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 Focus Group
Study Status Completed
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 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 The Focus Group study is a one time study designed to evaluate how easily patients   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 35 women in one of each of 4 groups. Two were held in Dallas, Texas   show the rest ...
Data Collection The study used two methods of data collection: discussion groups and a self-administered survey-- to   show the rest ...
Followup Visits and Length of Followup No Follow-up required
Final Study Results
Actual Number of Patients Enrolled 35 women distributed over 4 groups.
Actual Number of Sites Enrolled 2 (San Francisco and Dallas)
Patient Followup Rate not applicable
Final Safety Findings No safety findings. Key findings reported by sponsor are summarized here. Overall reaction to both   show the rest ...
Study Strengths and Weaknesses Discussion groups are useful for exploring attitudes, knowledge and beliefs. Readers should be cautious in   show the rest ...
Recommendations for Labeling Changes Add information clearly describing differences between restoration, replacement, reconstruction, and revision early in the main   show the rest ...


Focus Group Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Focus Group Study Final Report 11/17/2007 11/16/2007 On Time

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