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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 P020016
Current Protocol Accepted 09/21/2005
Study Name Longterm Followup Study
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 follow-up of the pre-market study patients.
Study Population Description Study Population: All patients remaining at approval of device. Indication: For reconstruction of the temporomandibularjoint.   show the rest ...
Sample Size 150 patients, 8 sites
Data Collection The primary endpoints include quality of life, jaw pain, jaw function and, maximum interincisal opening,   show the rest ...
Followup Visits and Length of Followup Patients will be followed for 3-years post implant. The follow-up schedule was not noted.
Final Study Results
Actual Number of Patients Enrolled 288
Actual Number of Sites Enrolled Not stated
Patient Followup Rate 91%
Final Safety Findings Of the enrolled patients, 98.4% of known patients retained the implant at three years. However,   show the rest ...
Study Strengths and Weaknesses The strength of the study is that there is adequate follow-up. The weaknesses of the   show the rest ...
Recommendations for Labeling Changes There were no recomendations were made for labeling changes.


Longterm Followup Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Request extension for 1 year report 09/22/2006 09/22/2006 On Time
1 year report 12/20/2006 12/21/2006 Overdue/Received
2 year report 09/21/2007 09/25/2007 Overdue/Received
Final Report 10/31/2008 11/03/2008 Overdue/Received

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