(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]