CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR882.5855]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 882 -- NEUROLOGICAL DEVICES

Subpart F - Neurological Therapeutic Devices

Sec. 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.

[88 FR 751, Jan. 5, 2023]