§ 882.1565 Brain temperature measurement system.
(a) Identification. A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) In vivo performance testing must demonstrate that the device performs as intended for its anticipated conditions of use and can accurately and reliably measure brain temperature compared to a ground truth measurement.
(2) Non-clinical performance testing must demonstrate that the device can accurately measure changes in brain temperature under simulated conditions of use. Testing must assess repeatability within pre- specified, clinically relevant parameters. The technical specifications of the device's hardware and software must be fully characterized.
(3) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility testing must be performed.
(4) Software documentation must include a detailed technical description of the algorithm(s) used to generate the device output(s), and be accompanied by verification and validation testing to ensure device and algorithm functionality as informed by the software requirements and hazard analysis.
(5) The tissue contacting device components must be demonstrated to be biocompatible.
(6) Usability evaluation must demonstrate that the intended user(s) can safely and correctly use the device, based solely on reading the directions for use.
(7) Labeling must include:
(i) Instructions for use, including a detailed description of the device and explanation of all device outputs.
(ii) The following warnings:
(A) A statement that the device is not intended to measure core body temperature, and to use an independent thermometer to measure core body temperature.
(B) Conditions of use that may impact the accuracy and reliability of the device measurement.
(C) Conditions of use that may affect skin integrity or cause skin injury, such as extended wear duration or placement of the device on damaged or compromised skin, skin lesions, or open wounds.
(D) Limitations of device use to inform diagnosis or therapy.
(E) Summaries of in vivo testing conducted to demonstrate how the device functions as intended.
(F) The summary must include the following:
(G) A description of each device output.
(H) A description of the study population and the use environment.
(I) The methods used to collect temperature data.
(J) Any observed adverse events and complications.
[91 FR 23165, Apr. 30, 2026]