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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 882 - Neurological Devices |
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Subpart F - Neurological Therapeutic Devices |
§ 882.5855 - Brain stimulation programming planning software.
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§ 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]