The US Food and Drug Administration (FDA) is proposing to reclassify yet another medical device, this time blade-form endosseous dental implants, as class II moderate-risk medical devices capable of being cleared through the 510(k) substantial equivalence process-the third such reclassification proposal this week.
The process stems from the 1976 Medical Device Amendments, which for the first time in US history established a system for the regulation of medical devices based on their safety and efficacy. Devices in distribution after the passage of the MDA were automatically classified as class III risk-risk devices until the agency has a chance to assess them based on their safety.
In other words, devices are assumed to be dangerous until proven otherwise (the de novo pathway partially alters this paradigm).
Devices are down-classified from class III to classes II or I through a three-part process involving the recommendation of an advisory committee, the publication of its recommendation in the Federal Register (and receipt of public comment) and the publication of a final regulation classifying the device.
Today's (11 January 2013) announcement means that FDA is in the second stage of its down-classification procedure, and is seeking to regulate blade-form endosseous dental implants as class II devices with special controls. The devices are relatively common, comprising the majority of all dental implants manufactured and sold in the US. The implants, generally made of titanium, are placed into the jaw, where the bone then fuses to the metal.
The devices were first approved in 1980, just a few years after the passage and implementation of the MDA. Because it is an implantable device, it was recommended by an FDA panel for classification as a class III medical device. In 1987, that recommendation was codified in a final rule.
In 1997, an FDA panel said many dental implants products, including root-form and temporary implants, could be marketed using a 510(k) using special controls, but said additional information was needed to support a similar conclusion for blade-form endosseous dental implants.
Now, FDA is proposing that the device be classified as a class II device with special controls as well, saying that the controls "would provide reasonable assurance of their safety and effectiveness."
"Absent the special controls identified in this proposed order, general controls applicable to the device are insufficient to provide reasonable assurance of the safety and effectiveness of the device," it added.
FDA explained that the devices are capable of causing a number of harms to patients if insufficiently controlled, including damage to tissue, pain, bone and nerve damage, infection and thermal injury if used in the presence of an MRI.
FDA's reclassification notice concludes with nine factors companies will have to meet if they are to market the device under the premarket notification system. Companies will need to conduct design and material composition testing, mechanical performance testing under simulated conditions, corrosion testing, biocompatibility testing, sterility testing, and must also have clear product labeling, patient labeling and document clinical experience of safety and efficacy.