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The U.S. Food and Drug Administration (FDA) has released a proposal to reclassify blade-form endosseous dental implants, opening the door for a possible resurgence of this implant technology.
The benefits of blade-form implants "outweigh the risks enough to justify reclassifying the implants from class III, requiring premarket approval, to class II, requiring premarket notification with special controls," the FDA noted in a press release.
Class II medical devices are of "medium risk," while class III is a "high risk" medical device that is also highly regulated. The FDA previously considered reclassifying blade implants in the 1990s but opted not to, stating that "sufficient evidence had not yet been presented to reclassify blade-form endosseous dental implants to class II." As more information has become available, the FDA has modified its position.
The agency plans to apply special controls, including design requirements, mechanical performance testing, corrosion testing under simulated physiological conditions, biocompatibility requirements, sterility testing, testing to ensure device compatibility with magnetic resonance environments, both clinical and patient labeling requirements, and documented clinical experience, including data on adverse events.
A comment period deadline of April 15 is set.
More information from drbicuspid
The U.S. Food and Drug Administration (FDA) has released a proposal to reclassify blade-form endosseous dental implants, opening the door for a possible resurgence of this implant technology.
The benefits of blade-form implants "outweigh the risks enough to justify reclassifying the implants from class III, requiring premarket approval, to class II, requiring premarket notification with special controls," the FDA noted in a press release.
Class II medical devices are of "medium risk," while class III is a "high risk" medical device that is also highly regulated. The FDA previously considered reclassifying blade implants in the 1990s but opted not to, stating that "sufficient evidence had not yet been presented to reclassify blade-form endosseous dental implants to class II." As more information has become available, the FDA has modified its position.
The agency plans to apply special controls, including design requirements, mechanical performance testing, corrosion testing under simulated physiological conditions, biocompatibility requirements, sterility testing, testing to ensure device compatibility with magnetic resonance environments, both clinical and patient labeling requirements, and documented clinical experience, including data on adverse events.
A comment period deadline of April 15 is set.
More information from drbicuspid
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