The Food and Drug Administration is set to publish a final rule in the Federal Register on Friday that would formally classify a new “virtual reality behavioral therapy device for pain relief” as a class II medical device.
The rule, an unpublished version of which was made available on Thursday, noted that FDA received a request from Los Angeles-based medical technology firm AppliedVR in March 2021 for a risk-based classification of a virtual reality device designed for the treatment of chronic lower back pain—known as RelieVRx and, formerly, EaseVRx—and issued an order in November 2021 granting “De Novo approval” of the device…
“We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use,” the final rule said. “After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls.”
The rule noted that FDA decided to go with a class II designation, rather than the automatic class III designation through the De Novo approval process, because the agency believes that “this action will enhance patients’ access to beneficial innovation.” … Read the full article here.