21 CFR 882.5855
§ 882.5855 Brain stimulation programming planning software.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.5855, § 882.5855 Brain stimulation programming planning software, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90747
- Permanent ID
ys:prov:90747@1- SHA-256
eb452d732dd2e66fe6ff94d396bc42094b4ee45f8339a7eb448b99759795011b
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.