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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 P070004
Current Protocol Accepted 06/07/2012
Study Name Focus Group Study
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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Focus Group Study
Study Population Description Women interested in breast augmentation or reconstruction with Sientra Silicone Gel Breast Implants.
Sample Size Four focus groups with 8-10 participants in each group in Los Angeles, CA and Dallas, TX.
Data Collection Participants¿ answers to the questions regarding the effectiveness of patient labeling in communicating the risks   show the rest ...
Followup Visits and Length of Followup N/A

N/A

Final Study Results
Actual Number of Patients Enrolled 37 (18 in the augmentation group and 19 in the reconstruction group)
Actual Number of Sites Enrolled 2
Patient Followup Rate n/a
Final Safety Findings In general, feedback from the four groups was positive and most participants found the



Brochures   show the rest ...
Study Strengths and Weaknesses The focus group study is quick, usually inexpensive, and useful in exploring ideas and concepts   show the rest ...
Recommendations for Labeling Changes No labeling change is recommended. The Focus Group Study was conducted to evaluate Patient Educational   show the rest ...


Focus Group Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
final report 03/07/2013 03/08/2013 Overdue/Received

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