This proposed reclassification would ensure premarket approval would no longer be mandatory to effectively mitigate possible health risks.
The U.S. market for dental implants is valued at just under $495 million and growing. The global financial crisis of 2008 and 2009 greatly impacted sales of dental implants during that period, sending the market into a decline. However, in 2010 the implant market appeared to undergo a recovery; a trend that continues today as the baby boomer population ages.
Over the last decade, the percentage of the U.S. and European population over the age of 65 has been increasing annually. Older patients are far more likely to be edentulous than younger generations, and as a result, are much more likely to require dentures. As implant-supported dentures become more recognized and accepted in the implant community.
Currently, the FDA is proposing to reclassify blade-form endosseous implants implants from Class III to Class II devices. It recognizes three classes of medical devices based on the level of control necessary to assure safety and effectiveness. While medium risk Class II devices are subject to general and special controls, Class III devices are highly regulated. Typically Class III devices support or sustain human life, or are of substantial importance in preventing impairment of human health. However, they may present a potential, unreasonable risk of illness or injury. For Class III devices, premarket approval is often required to ensure safety and effectiveness.
In addition to complying with general controls, these implants would be subject to special controls, including special labelling requirements, mandatory performance standards and post-market surveillance. However, premarket approval would no longer be mandatory to effectively mitigate possible health risks, including infection and adverse tissue reactions.
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