21 CFR 890.5800 — Virtual Reality Behavioral Therapy Device For Pain Relief
Neurology (NE) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5800
Identification
A virtual reality behavioral therapy device for pain relief is a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display that utilizes a software program containing the behavioral therapy content.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QRA | Virtual Reality Behavioral Therapy Device For Pain Relief | 2 | 6 | SaMD |
Special Controls
QRA — Virtual Reality Behavioral Therapy Device For Pain Relief
*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance testing under the labeled conditions for use must validate the model of behavioral therapy as implemented by the device and evaluate all adverse events. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Software verification, validation, and hazard analysis must be performed. (4) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed. (5) Labeling must include the following: (i) A warning regarding the risk of nausea and motion sickness; (ii) A warning regarding the risk of discomfort from the device; and (iii) A summary of the clinical testing with the device.
eCFR
QRA — Virtual Reality Behavioral Therapy Device For Pain Relief
(1) Clinical performance testing under the labeled conditions for use must validate the model of behavioral therapy as implemented by the device and evaluate all adverse events. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Software verification, validation, and hazard analysis must be performed. (4) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed. (5) Labeling must include the following: (i) A warning regarding the risk of nausea and motion sickness; (ii) A warning regarding the risk of discomfort from the device; and (iii) A summary of the clinical testing with the device.
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