FDA codifies eight De Novo device types as Class II, three years after granting them

FDA published eight device classification regulations on September 10, running from 91 FR 57493 to 57511. All eight took effect the same day. Each one converts a De Novo grant from 2023 into a codified Class II regulation with special controls.

The new sections and the companies behind them: 21 CFR 870.4600, extravascular support for an arteriovenous fistula, from Laminate Medical Technologies' VasQ. 21 CFR 870.5710, mechanical deviation device for esophageal protection, from S4 Medical's esolution Esophageal Retractor. 21 CFR 870.5720, temperature regulation device for esophageal protection, from Attune Medical's ensoETM. 21 CFR 874.4460, cooperative powered surgical assist device for ENT surgery, from Galen Robotics' Galen ES.

The rest: 21 CFR 876.5305, implanted tibial electrical urinary continence device, from BlueWind Medical's Revi System. 21 CFR 880.6510, whole room microbial reduction device, from Xenex Disinfection Services' LightStrike+. Plus a clinical chemistry classification for an anti-tumor necrosis factor alpha monoclonal antibody test system and a radiology classification for a vaginal hydrogel packing system.

The lag is the part to note. Xenex won its De Novo on September 1, 2023, and S4 Medical won its on September 6, 2023. Both regulations took effect three years later. Until codification, the special controls live only in the classification order, and a second entrant has a harder time citing them in a 510(k).

For anyone building in one of these eight spaces, September 10 is the date the cheaper path opened. The same device type can now go 510(k) against a published regulation instead of funding a De Novo of its own.

Questions & Answers

What device classification regulations did FDA publish on September 10, 2026?

FDA published eight Class II device classification regulations in the Federal Register on September 10, 2026, running from 91 FR 57493 to 91 FR 57511. They cover extravascular support for an arteriovenous fistula, two esophageal protection devices, an anti-TNF alpha antibody test system, a cooperative powered surgical assist device for ENT surgery, an implanted tibial electrical urinary continence device, a whole room microbial reduction device and a vaginal hydrogel packing system.

Why does codifying a De Novo classification matter for a medical device startup?

Once FDA codifies a De Novo grant as a classification regulation, a later company with the same device type can file a 510(k) against that regulation instead of preparing its own De Novo request. The special controls are then published in the Code of Federal Regulations rather than sitting only in the original classification order.

How long did FDA take to codify the Xenex LightStrike+ De Novo?

FDA granted the De Novo for Xenex Disinfection Services' LightStrike+ on September 1, 2023. The resulting classification regulation for the whole room microbial reduction device, 21 CFR 880.6510, was published and took effect on September 10, 2026, just over three years later.

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