FDA Set to Issue Final Rule Classifying VR Therapy Device for Pain Relief - Nextgov

The Food and Drug Administration is acceptable to people a last regularisation successful the Federal Register connected Friday that would formally classify a caller “virtual world behavioral therapy instrumentality for symptom relief” arsenic a class II aesculapian device.

The rule, an unpublished mentation of which was made disposable connected Thursday, noted that FDA received a petition from Los Angeles-based aesculapian exertion steadfast AppliedVR successful March 2021 for a risk-based classification of a virtual world instrumentality designed for the attraction of chronic little backmost pain—known arsenic RelieVRx and, formerly, EaseVRx—and issued an bid successful November 2021 granting “De Novo approval” of the device. 

The FDA uses 3 antithetic classification categories for aesculapian devices, with class I designation signaling that a instrumentality presents “minimal imaginable for harm to the user.” The people II designation, which encompasses astir aesculapian devices, is for products that connection a mean to precocious hazard for users and see general controls and peculiar controls designed to mitigate risk. Class III is typically reserved for devices that “usually prolong oregon enactment life, are implanted oregon contiguous imaginable unreasonable hazard of unwellness oregon injury,” though immoderate devices person an automatic people III designation by going done the De Novo support process. 

“We classify devices into people II if wide controls by themselves are insufficient to supply tenable assurance of information and effectiveness, but determination is capable accusation to found peculiar controls that, successful operation with the wide controls, supply tenable assurance of the information and effectiveness of the instrumentality for its intended use,” the last regularisation said. “After reappraisal of the accusation submitted successful the request, we determined that the instrumentality tin beryllium classified into people II with the constitution of peculiar controls.”

The regularisation noted that FDA decided to spell with a people II designation, alternatively than the automatic people III designation done the De Novo support process, due to the fact that the bureau believes that “this enactment volition heighten patients’ entree to beneficial innovation.”

FDA’s last regularisation noted that the bureau identified respective risks to wellness associated with the device, including adverse insubstantial reaction, electrical shock, pain oregon interference with different devices, nausea and question sickness, discomfort, improper instrumentality usage and ineffective treatment. But FDA besides outlined the measures required to mitigate the imaginable risks and said it determined that “special controls, successful operation with the wide controls, code these risks to wellness and supply tenable assurance of information and effectiveness.”

A press release issued by AppliedVR successful November 2021 pursuing the FDA’s designation of De Novo support for the instrumentality said that RelieVRx “is a prescription-use aesculapian instrumentality with preloaded bundle contented connected a proprietary hardware platform” that uses “an immersive virtual world strategy that delivers VR contented portion incorporating biopsychosocial symptom education, diaphragmatic breathing training, mindfulness exercises, relaxation-response exercises and enforcement functioning games.” 

The institution added that the device’s bundle contented “comprises an eight-week, VR-based programme that helps radical trim grounds severity and the interaction of their pain.”

In summation to backstage companies exploring the usage of VR-focused aesculapian devices, national agencies successful caller years person besides begun moving to incorporated new, immersive technologies into the healthcare setting. The Department of Veterans Affairs, successful particular, has been investigating the usage of these types of aesculapian devices, including working with veterans since 2017 to usage virtual world programming arsenic a means of managing symptom and anxiety.