Newsletter
SILVER SPRING, Md., USA: The Food and Drug Administration has proposed a reclassification of blade-form endosseous dental implants commonly used in dental restoration from Class III to Class II devices, reducing the regulatory requirements for marketing these implants.
The FDA recognizes three classes of medical devices based on the level of control necessary to assure safety and effectiveness. While Class II devices, i.e. medium-risk devices, are subject to general and special controls, Class III devices are highly regulated. Usually, Class III devices support or sustain human life, or are of substantial importance in preventing impairment of human health, but may present a potential, unreasonable risk of illness or injury. In many cases, premarket approval is required to ensure the safety and effectiveness of these devices.
The FDA said that it has proposed the reclassification of blade-form endosseous dental implants based on new information regarding their health benefits and risk incidences published since the organization's prior recommendation. "FDA has been reviewing these devices for many years and their risks are well known. A review of the applicable clinical literature indicates that the device has a high success rate 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 organization stated.
In addition to complying with general controls, the implants would be subject to special controls, including special labeling requirements, mandatory performance standards and postmarket surveillance. However, premarket approval would no longer be mandatory to effectively mitigate possible health risks, including infection and adverse tissue reactions.
Electronic or written submissions on the proposal can be submitted by April 15, the organization stated.
