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US Regulators Move to Reclassify Medical Device as Class III

Posted 09 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) announced Friday, 6 July that it wants to require sponsors of shortwave diathermy (SWD) devices to file either a premarket approval application (PMA) or complete a product development protocol (PDP) for all but one of the device's indications.

SWDs are used to generate deep heat in body tissues using electromagnetic energy. Though they are primarily used to raise the heat of the body tissue, some medical device manufacturers have indicated the device may be used to help treat malignancies. Though FDA said SWD's original indication for generating deep heat may continue to be classified as a lower-risk device, "all other uses" will be given a class III indication.

Re-classifying Pre-amendment Medical Devices

In its Federal Register posting, FDA explained the devices were first introduced to the market before the 1976 Medical Device Amendments (MDA) or the 1990 Safe Medical Devices Act (SMDA) came into effect, both of which largely established the US' medical device regulatory system as it exists today. Under the MDA, devices already on the market were not subject to the new regulatory system unless FDA specifically classified them through a lengthy procedure.

FDA explained it has already "classified most pre-amendments devices," and is in the process of classifying the remaining ones. (See Regulatory Focus' 6 July story, "US Regulators Reclassify Pacemaker Electrodes as Higher-risk Devices.")

In proposing the new classification, FDA said it is acting upon the recommendation of its Physical Medicine Device Classification Panel advisory committee, which found insufficient evidence to support the assurance of safety of the devices using class II general or special controls. Among the risks to patients include cellular or tissue injury, pacemaker interference, tissue necrosis, cutaneous burns, electrical shock, thermal injury, radiation hazards and abnormal cell growth.

"We believe that health care providers and patients currently have incomplete information concerning the safety and effectiveness of these [SWD] devices," FDA explained. "This lack of information causes them to direct resources toward treatments they would not otherwise choose."

Sponsors would be charged considerably more under the rule. PMAs are estimated to cost between $1.2 and $4.7 million, with the majority of the cost being borne by clinical trials, which FDA notes can cost upward of $10,000 per patient to complete. "FDA expects to review one or fewer PMAs for affected devices should a final rule be issued," the agency explained.

The comment period on FDA's proposal end 4 October 2012.

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