21 CFR §882.5855

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.