---
kind: "section"
citation: "21 C.F.R. § 882.5855"
title: "21"
number: "882.5855"
heading: "Brain stimulation programming planning software."
url: "https://uscodex.org/cfr/21/882.5855"
---

# §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.**

## Notes

### Amendments

[88 FR 751, Jan. 5, 2023]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[88 FR 751, Jan. 5, 2023]