- (a) Identification. An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use, including the following:
- (i) Electrical output testing;
- (ii) Mechanical integrity testing of electrical components;
- (iii) Testing to verify safe use of the electrical stimulator component in the presence of supplementary oxygen; and
- (iv) If the device incorporates a feeding tube, feeding tube functionality testing, including mechanical integrity, liquid leakage, flow rate and connector compatibility.
- (2) The patient-contacting components of the device must be demonstrated to be biocompatible.
- (3) Performance testing must demonstrate the sterility of the components intended to be provided sterile.
- (4) Performance data must validate the reprocessing instructions for any reusable components of the device.
- (5) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
- (6) Software verification, validation and hazard analysis must be performed for any software components of the device.
- (7) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of any electrical components.
- (8) A training program must be included with sufficient educational elements so that upon completion of the training program, the user can correctly operate the device.
- (9) Usability testing must demonstrate that the device can be correctly used as per training and labeling.
- (10) The labeling must include a shelf life for any sterile components.
[91 FR 32346, June 1, 2026]