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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
Most Recent Protocol Version Approved 11/17/2006
Study Name Focus Group
Study Status Completed
General Study Protocol Parameters
Study Design Other Study Design
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 There were 6 focus groups planned, each included 10 breast implant patients. In the moderator   show the rest ...
Study Population Description The study population is as per device indication. The device is indicated for breast augmentation   show the rest ...
Sample Size 10 patients in a each of 6 focus groups
Data Collection Recommendations on the patient planner and labeling were suggested by participants in the focus group.   show the rest ...
Followup Visits and Length of Followup N/A, There is no follow-up of focus group participants.
Final Study Results
Actual Number of Patients Enrolled There were 29 augmentation participants and 23 reconstruction participants.
Actual Number of Sites Enrolled N/A
Patient Followup Rate N/A, There was no follow-up of focus group participants.
Final Safety Findings N/A, There are no safety findings.
Study Strengths and Weaknesses The strength of the study was that the focus groups included augmentation and reconstruction patients.   show the rest ...
Recommendations for Labeling Changes Changes were made to the Patient Planner based on the recommendatin of the focus groups.   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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