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FDA Announces Four New Device Classifications

 
• By Elizabeth Orr

The devices include a digital therapeutic to treat ADHD and a tongue muscle stimulator to prevent sleep apnea and snoring. They all initially reached market via the de novo process and have now been declared class II.

FDA building with sign

The US Food and Drug Administration has announced classifications for four device types that first reached market via the de novo pathway. All four of the device types are being placed into class II, according to announcements set to run in the 3 September Federal Register.

The de novo pathway is reserved for devices that are not considered high risk but are ineligible for 510(k) because...

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