The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) finalized on Tuesday the classification of the auto titration device for oral appliances into class II with special controls.
The final order sets the new regulation on the dental device type based on the regulatory review of the 2017 de novo classification request CDRH granted to Zephyr Sleep Technologies’ MATRx plus, classifying the device into class II in August 2018. It codifies the classification of the new device type and comes after the agency finalized
a de novo rule last December to bypass the proposed rulemaking process.
A device would be required to comply with the special controls identified in the final order to fall within the new classification regulation. These relate to the identified risks, including adverse tissue reaction, infection and disruption of sleep, among others. The final order tied a set of mitigation measures to each of the potential risks to health, including biocompatibility evaluation and labeling, among others.
By complying with the noted special controls, an auto titration device for oral appliances can avoid being automatically classified into class III. This is part of CDRH’s efforts to classify more device types that can be evaluated through the less burdensome 510(k) pathway for class II devices rather than the more data-intensive premarket approval application (PMA) pathway for class III devices.
A 2013 report
from the Office of Inspector General at the US Department of Health and Human Services found that the agency had not “finished classifying all types of class II devices cleared through the 510(k) process, as required by Congress in 1990” and it had continued to “clear some class III devices through the 510(k) process” as a result. CDRH issued
a report last November that indicated the agency had cleared about 80 submissions for class III devices through the 510(k) process between 2003 and 2009.
But the CDRH report goes on to note that the agency published 24 final rules between 2011 and 2016 and issued proposed orders to either down-classify device types to class I or class II or require PMAs to eliminate the use of the 510(k) process for high risk medical devices. “As a result of these actions, not a single class III device was cleared via the 510(k) process” in fiscal year 2018, according to CDRH’s report.
Still, the agency did not stop at the 25 class III device types that were still eligible for the 510(k) process as of August 2009. Last year, a plethora
of new device types were classified into class I or class II. These include certain radiological imaging devices
and female condoms
, among others
. In 2017, the agency also finalized a list of 1,003 device types for exemption of 510(k) requirements. Further, a 2015 final guidance document was revised
earlier this month on 510(k) exemptions for unclassified devices. These efforts form part of a larger CDRH initiative to reduce regulatory burden
on industry and agency staff.