§ 882.5855 - Brain stimulation programming planning software.

§ 882.5855 Brain stimulation programming planning software.

(a) Identification. The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Software verification, validation, and hazard analysis must be performed.

(2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.

(3) Labeling must include:

(i) The implanted brain stimulators for which the device is compatible.

(ii) Instructions for use.

(iii) Instructions and explanations of all user-interface components.

(iv) A warning regarding use of the data with respect to not replacing clinical judgment.

[88 FR 751, Jan. 5, 2023]