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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 P050033
Current Protocol Accepted 04/29/2008
Study Name Elevess CTA Study
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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a 24-week, multi-center, single arm prospective cohort study. All subjects in the   show the rest ...
Study Population Description The device is indicated for injection into the mid to deep dermis for the correction   show the rest ...
Sample Size 100 subjects, 9 sites
Data Collection Endpoints include observed and reported adverse events at each visit and in a subject diary.   show the rest ...
Followup Visits and Length of Followup Treatment visits will be conducted every 14 days until optimal cosmetic correction is obtained. Follow-up   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 122
Actual Number of Sites Enrolled 9
Patient Followup Rate 96%
Final Safety Findings

Of the 122 patients enrolled, a total of 100 were included in the analysis.

(1) No   show the rest ...
Final Effectiveness Findings Not applicable
Study Strengths and Weaknesses Strengths:

¿The high follow-up rate of 96% for 100 subjects minimizes the potential bias that   show the rest ...
Recommendations for Labeling Changes Yes, to update the AEs for Fitzpatrick skin types IV-VI



Elevess CTA Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 12/20/2007 12/26/2007 Overdue/Received
18 month report 10/29/2008 11/14/2008 Overdue/Received
2 year report 12/19/2008 12/19/2008 On Time
3 year report 12/21/2009 12/18/2009 On Time
study status report 07/13/2010 07/13/2010 On Time
Final report 09/30/2010 09/30/2010 On Time

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