The US FDA (Food & Drug Administration) has 3 regulatory classes for devices. Class I devices (low to moderate risk) present the potential of minimal harm to the user, such as elastic bandages. Class II devices (moderate to high risk) have special controls established to provide reasonable assurance of the safety and effectiveness of the device, and examples include powered wheelchairs and CPAP devices (positive airway pressure delivery systems). Class III devices (high risk) sustain or support life, such as implantable pacemakers, and are subject to premarket approval (PMA).
By default, when a new type of device is submitted to the FDA for approval, it is classified as a Class III device (regardless of its actual risk level). But the FDA can reclassify it as a lower risk level later, which then lowers the regulatory burdens on similar devices that seek approval in the future—enhancing “patients’ access to beneficial innovative devices,” according to the FDA.
The FDA recently issued a final order to reclassify auto titration devices for oral appliances to Class II devices. The order is effective February 20, 2019.
This reclassification comes after the FDA received a De Novo classification request on Dec 21, 2017, from Zephyr Sleep Technologies for its MATRx plus. On August 23, 2018, the FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 872.5571. “We have named the generic type of device auto titration device for oral appliances, and it 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,” the agency said in its final order.
For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in the final order, which are:
Clinical performance testing must evaluate the following:
- Performance characteristics of the algorithm; and
- All adverse events.
Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:
- Validation of the closed loop algorithm;
- Mechanical integrity over the expected use life;
- Characterization of maximum force, distance, and speed of device movement; and
- Movement accuracy of intraoral components.
Performance testing must demonstrate the wireless compatibility, electrical safety, and electromagnetic compatibility of the device in its intended use environment.
Software verification, validation, and hazard analysis must be performed.
The patient-contacting components of the device must be demonstrated to be biocompatible.
Performance data must validate the reprocessing instructions for any reusable components.
Patient labeling must include:
- Information on device use, including placement of sensors and mouthpieces;
- A description of all alarms; and
- Instructions for reprocessing any reusable components.
A human factors assessment must evaluate simulated use of the device in a home use setting.