Jaw devices should be classified in US:
This article was originally published in Clinica
Devices for diagnosing and managing temporomandibular joint (TMJ) dysfunction and orofacial pain should be classified as Class I products in the US, which will require 510(k) clearance, an FDA advisory panel has said. These devices, which were previously unclassified, include sonogram systems for measuring sound from the jaw to assess TMJ dysfunction and jaw tracking devices (kinesiographs) for analysing the anatomy of the jaw and tracking its movement to assess how well orthodontic devices work.
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