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]