Effective Feb. 20, 2019, the U.S. Food and Drug Administration (FDA) has issued a final order that reclassifies the “auto titration device for oral appliances” as class II (special controls). This type of device is identified as “a prescription home use device that determines a target position to be used for a final oral appliance for the reduction of snoring and mild to moderate obstructive sleep apnea.”
This reclassification comes after the FDA received a De Novo classification request on Dec. 21, 2017, from Zephyr Sleep Technologies for the MATRx plus. Its original classification was class III, as all devices that were not in commercial distribution before May 28, 1976, are automatically classified as class III, requiring premarket approval unless the FDA takes an action to classify or reclassify them. The FDA believes that changing the classification will enhance patients’ access to beneficial innovation and provide reasonable assurance of safety and effectiveness of the device. The FDA made a similar announcement in October 2018 when it reclassified the positive airway pressure (PAP) delivery system, moving it from Class III into Class II.
Per the reclassification to Class II (special controls), the special controls for the auto titration device for oral appliances are:
(1) Clinical performance testing must evaluate the following:
(i) Performance characteristics of the algorithm; and
(ii) All adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:
(i) Validation of the closed loop algorithm;
(ii) Mechanical integrity over the expected use life;
(iii) Characterization of maximum force, distance, and speed of device movement; and
(iv) Movement accuracy of intraoral components.
(3) Performance testing must demonstrate the wireless compatibility, electrical safety, and electromagnetic compatibility of the device in its intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Performance data must validate the reprocessing instructions for any reusable components.
(7) Patient labeling must include:
(i) Information on device use, including placement of sensors and mouthpieces;
(ii) A description of all alarms; and
(iii) Instructions for reprocessing any reusable components.
(8) A human factors assessment must evaluate simulated use of the device in a home use setting.
Read the full FDA announcement, “Medical Devices; Dental Devices; Classification of the Auto Titration Device for Oral Appliances.”