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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 P050037
Current Protocol Accepted 12/22/2006
Study Name Radiesse
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 is a prospective cohort study desgined to extend the follow-up patients enrolled in the   show the rest ...
Study Population Description This device is indicated for subdermal implantation for restoration and/or correction of the signs of   show the rest ...
Sample Size 98 patients, 3 sites
Data Collection At the 18-month visit, subjects had a Global Aesthetic Improvement Scale assessment, photograph, skin thickness   show the rest ...
Followup Visits and Length of Followup The study required 18 month follow-up. As a part of the post-market requirement, study participants   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 92 patients
Actual Number of Sites Enrolled 3 sites
Patient Followup Rate 92%
Final Safety Findings Adverse events including allergic reaction, ecchymosis, edema, embolization, erosion, erythema, extrusion, granuloma, hematoma, infection, necrosis,   show the rest ...
Study Strengths and Weaknesses The weakness of the study was that there was no control group.
Recommendations for Labeling Changes Labeling change were submitted by the manufacturer. The revisions submitted by the sponsor were not   show the rest ...


Radiesse Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
18 month report (follow-up IDE Cohort) 02/09/2007 02/09/2007 On Time

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