WASHINGTON (CN) - The Food and Drug Administration plans to reclassify a blade-form surgically-implanted dental device, citing the benefits of such devices relative to their risks.
The blade-form endosseous dental implant is a kind of device, made of titanium alloy or other so-called biocompatible material, that is surgically installed into a patient's jaw bone. A denture, crown, bridge or similar dental restoration is attached to the implant by means of a screw extending into the patient's mouth, the proposal states.
The FDA's proposal acknowledges health risks associated with the implants, including tissue degeneration, pain, bone and nerve damage, infection, and immune reactions to materials in the devices. However, the agency believes the benefits outweigh the risks enough to justify reclassifying the implants from class III, requiring premarket approval, to class II, requiring premarket notification with special controls.
Between 1991 and 1998, the FDA considered reclassifying the devices, but at that time decided not to, because "sufficient evidence had not yet been presented to reclassify blade-form endosseous dental implants to class II," according to the proposal.
As more information became available, the FDA changed its stance.
"A review of the applicable clinical literature indicates that the device has a high success rate (remaining implanted/not removed) and that few relevant adverse events have been reported in the case of these devices or related devices suggesting that the device has a high long-term safety profile," the proposal states.
The proposal spells out the special controls the agency plans to apply. These include design requirements, mechanical performance testing, corrosion testing under simulated physiological conditions, biocompatibility requirements, sterility testing, testing to assure device compatibility with magnetic resonance environments, both clinical and patient labeling requirements, and documented clinical experience including data on adverse events.
The comment deadline is April 15.
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