§ 872.5560. Electrical salivary stimulatory system.
153 words·~1 min read·
/us/cfr/t21/s§ 872.5560·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An electrical salivary stimulatory system is a prescription intraoral device that is intended to electrically stimulate a relative increase in saliva production.
(b)Classification—Class II (special controls). The special controls for this device are:
(1)The design characteristics of the device must ensure that the device design, material composition, and electrical output characteristics are consistent with the intended use;
(2)Any element of the device that contacts the patient must be demonstrated to be biocompatible;
(3)Appropriate analysis and/or testing must validate electromagnetic compatibility and electrical safety, including the safety of any battery used in the device;
(4)Software validation, verification, and hazard testing must be performed; and
(5)Documented clinical experience must demonstrate safe and effective use for stimulating saliva production by addressing the risks of damage to intraoral tissue and of ineffective treatment and must capture any adverse events observed during clinical use. [80 FR 72586, Nov. 22, 2015]
Connections1 cite this
Cited by 1 section
register
Citation graph
cites case law
§ 872.5560
Electrical salivary stimulatory system.
Fed. Reg.×1
Cites 0Cited by 1 across 1 source