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

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

   1. (1) Software verification, validation, and hazard analysis must be performed.
   2. (2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.

   3. (3) Labeling must include:

      1. (i) The implanted brain stimulators for which the device is compatible.
      2. (ii) Instructions for use.
      3. (iii) Instructions and explanations of all user-interface components.
      4. (iv) A warning regarding use of the data with respect to not replacing clinical judgment.

[88 FR 751, Jan. 5, 2023]