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Home » Sonex Health presses FDA to avoid down-classification of SX-One device
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Sonex Health presses FDA to avoid down-classification of SX-One device

June 16, 2023
By Mark McCarty
The U.S. FDA’s citizen’s petition process doesn’t always yield the desired outcome, but the agency must nonetheless respond to these petitions. Sonex Health Inc., has petitioned the FDA to rethink a proposal to reclassify the company’s SX-One device for treatment of carpal tunnel syndrome, an unusual instance in which a medical device maker has resisted a proposal to make a device exempt from regulatory requirements.
BioWorld MedTech Medical devices and technologies Regulatory U.S. FDA

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