FDA codifies four De Novo device types, including Samsung's sleep apnea feature

MedDevice Startups Staff · 1 day ago · 2 min read · Via FDA, CDRH news and updates

FDA published four device classification orders in the Federal Register on October 30, each creating a new Class II device type with special controls. The orders cover a spinal imaging system for neuraxial procedures, an over the counter device that assesses the risk of sleep apnea, software-aided diagnostic support for skin cancer lesions, and radiology software that refers findings related to fibrotic lung disease. CDRH posted them online on October 29.

Two of the regulations are now easy to look up. The spinal imaging system sits at 21 CFR 868.1985 under product code QXD, in the anesthesiology panel, and traces to DEN220009, IntuiTap Medical's VerTouch Spinal Imaging Device. The sleep apnea risk device sits at 868.2378 under product code QZW, from Samsung Electronics' Sleep Apnea Feature, authorized under DEN230041 in February 2024. The skin lesion type comes out of DermaSensor's DEN230008.

Codification is the part that changes a submission plan. A De Novo authorization sits with one company until FDA writes the regulation, and then the device type becomes a predicate anyone can cite with a published set of special controls to design against. For a startup working on wearable sleep apnea screening or point of care skin lesion assessment, the pathway question just moved from a De Novo request to a 510(k).

Questions & Answers

What four device types did FDA classify in the Federal Register on October 30, 2026?

FDA published classification orders creating four Class II device types: a spinal imaging system for neuraxial procedures, an over the counter device to assess the risk of sleep apnea, software-aided diagnostic support for skin cancer lesions, and radiology software that refers findings related to fibrotic lung disease. CDRH posted the orders online on October 29, a day before Federal Register publication.

What regulation and product code did FDA assign to the spinal imaging system for neuraxial procedures?

FDA put the spinal imaging system for neuraxial procedures at 21 CFR 868.1985 under product code QXD, in the anesthesiology panel. The device type originates in DEN220009, IntuiTap Medical's De Novo for the VerTouch Spinal Imaging Device.

Why does a new FDA classification regulation matter to a medical device startup?

A codified classification turns a one-off De Novo authorization into a device type any company can cite as a predicate, with written special controls. For the four types FDA classified on October 30, 2026, a startup can now target a 510(k) instead of filing its own De Novo request.

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