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While partly in recognition of our inability to evaluate every DMHT device, we proposed to define DMHT device under the proposed codes as devices cleared under section 510(k) of the FD&C Act or granted De Novo authorization by FDA and classified under 21 CFR 882.5801 in an effort to ensure our payment policies for DMHT devices are aligned with devices the FDA classified with special controls requiring clinical data to validate the model of behavioral therapy as implemented by the device