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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 P050052
Most Recent Protocol Version Approved 12/22/2006
Study Name Long Term (Nasolabial Folds)
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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is desgined to extend the follow-up patients enrolled in the premarket study. Patients   show the rest ...
Study Population Description This device is indicated for subdermal implantation for the correction of moderate to severe facial   show the rest ...
Sample Size 100 subjects, 4 sites
Data Collection There were no primary effectiveness endpoints defined. Patients were assessed for the late onset of   show the rest ...
Followup Visits and Length of Followup The study required 3 year follow-up. As a part of the post-market requirement, study participants   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 102 of the 117 patients who participated in premarket study enrolled 99 of the 102   show the rest ...
Actual Number of Sites Enrolled 4 sites
Patient Followup Rate 97%
Final Safety Findings No adverse events were reported by the study although its purpose was to collect long-term   show the rest ...
Study Strengths and Weaknesses The weakness of the study was that there was no control group. Study weaknesses inlcude   show the rest ...
Recommendations for Labeling Changes Update labeling to reflect the results of the PAS taking into account study limitations


Long Term (Nasolabial Folds) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report long term study 12/22/2007 01/14/2008 Overdue/Received
2 year report long term 12/21/2008 04/01/2008 On Time

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