§882.5855. Brain stimulation programming planning software.
21 C.F.R. § 882.5855
Identification. The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.
Classification. Class II (special controls). The special controls for this device are:
Software verification, validation, and hazard analysis must be performed.
Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
Labeling must include:
The implanted brain stimulators for which the device is compatible.
Instructions for use.
Instructions and explanations of all user-interface components.
A warning regarding use of the data with respect to not replacing clinical judgment.
Notes, amendments, and revision history
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]