§882.5804. Computerized behavioral therapy device for the treatment of fibromyalgia symptoms.
21 C.F.R. § 882.5804
Identification. A computerized behavioral therapy device for the treatment of fibromyalgia symptoms is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of fibromyalgia symptoms.
Classification. Class II (special controls). The special controls for this device are:
Clinical data must demonstrate that the device performs as intended under the anticipated conditions of use and include the following:
Evaluation of improvement in the symptoms of fibromyalgia; and
Evaluation of relevant adverse events.
Software verification, validation, and hazard analysis must demonstrate that the device performs as intended.
Physician and patient labeling must include the following:
Recommended treatment regimes, including frequency and duration of use; and
A summary of the clinical data for the device, including a discussion of adverse events.
Notes, amendments, and revision history
Amendments
[91 FR 38512, June 26, 2026]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.
Amendments
[91 FR 38512, June 26, 2026]