§ 882.5855. Brain stimulation programming planning software.
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/us/cfr/t21/s§ 882.5855·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 882.5855
Brain stimulation programming planning software.
Fed. Reg.×1
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