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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.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P020012
Current Protocol Accepted 10/27/2006
Study Name Study P521-01
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 is a multi-center, non-randomized, non-controlled post-approval study.
Study Population Description Subjects who agree to participate and are consecutively treated with Artefill in nasolabial folds (NLF).   show the rest ...
Sample Size The sample size is 1,000 subjects who agree to participate and are consecutively treated with   show the rest ...
Data Collection Endpoints include the incidence of granuloma, incidence of serious unanticipated adverse events (including their severity   show the rest ...
Followup Visits and Length of Followup 5 years
Patients will be evaluated at baseline before treatment is administered. Follow-up starts at the   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 1,008
Actual Number of Sites Enrolled 23
Patient Followup Rate 87% at 5 years
Final Safety Findings Granulomas were encountered in 17 of 1,008 subjects (1.69%). A total of 887 adverse events   show the rest ...
Final Effectiveness Findings Subject satisfaction remained high throughout the study. The majority (>83%) of subjects were very satisfied   show the rest ...
Study Strengths and Weaknesses This is a prospective, multicenter study that provides long term data up to 5 years   show the rest ...
Recommendations for Labeling Changes The labeling will be updated based on the 5쳌]year safety and effectiveness results reported in   show the rest ...

Study P521-01 Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
1 year report 10/27/2007 11/09/2007 Overdue/Received
2 year report 10/26/2008 10/27/2008 Overdue/Received
3 year report 10/26/2009 10/28/2009 Overdue/Received
4 year report 10/26/2010 10/26/2010 On Time
5 year report 10/26/2011 10/28/2011 Overdue/Received
6 year report 10/25/2012 10/25/2012 On Time
7 year report 10/25/2013 10/28/2013 Overdue/Received
final report 05/14/2014 05/20/2014 Overdue/Received

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