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FDA Orders Postmarket Surveillance of Certain TMJ Implants
Date:2/7/2011

t with their health care professional.  

TMJ implant manufacturers were required to collect postmarket data on their implants as part of the approval process. However, the data collected did not adequately address the timing or reasons for replacement, and the studies lost contact over the years with many of the enrolled patients.

The TMJ implant postmarket surveillance studies must address the following:

  • Time between initial implant and removal/replacement
  • Association between patient diagnosis and the timeframe between implant and removal/replacement
  • For replacement implants, the time between implant and subsequent removal/replacement
  • Reasons for removal/replacement of the implant
  • Associations between patient demographic and clinical data and the need or removal/replacement
  • Assessment of devices that have been removed from patients

As part of its review, the FDA will consider whether labeling changes, additional preclinical and clinical testing requirements, or other regulatory actions are necessary for these devices.  

For more information:

522 Postmarket Surveillance Studies

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm

522 Postmarket Surveillance Studies – Frequently Asked Questions

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance/ucm134497.htm

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries:  888-INFO-FDA

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SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
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