FDA turns three 2023 De Novos into Class II regulations, including histotripsy at 878.4405

Three device types picked up their own Class II regulations in the Federal Register on October 6, each effective that day. Focused ultrasound for non-thermal, mechanical tissue ablation lands at 21 CFR 878.4405. The hyperoxia monitoring device adjunct to pulse oximetry goes to 870.2720. High throughput DNA sequencing for hereditary cancer predisposition assessment goes to 866.6095.

Each rule codifies a De Novo grant from 2023. FDA classified HistoSonics' Edison System on October 6, 2023 under DEN220087, Masimo's ORi on October 12, 2023, and Invitae's Common Hereditary Cancers Panel on September 29, 2023. The rules publish the identification language and the special controls attached to each type.

For a follow-on sponsor this is the point where the pathway changes. A device that fits the identification can file a 510(k) against the regulation and its special controls, instead of filing a De Novo and arguing a new classification from scratch. The 878.4405 controls run to eight items that are easy to underestimate: chronic animal safety, the minimum drive voltages needed to sustain a bubble cloud, real-time treatment monitoring, and a labeling warning that ablation should only be considered in patients with sufficient functional reserve.

The identification text is narrow in each case. The 878.4405 device mechanically ablates soft tissue and is explicitly not intended to ablate thermally. The 866.6095 panel is not for screening, prenatal testing or standalone diagnosis. A device that steps outside those sentences is back on the De Novo track.

Questions & Answers

What did FDA classify on October 6, 2026?

FDA published three classification rules on October 6, 2026 creating Class II regulations for the focused ultrasound system for non-thermal, mechanical tissue ablation (21 CFR 878.4405), the hyperoxia monitoring device adjunct to pulse oximetry (870.2720), and the high throughput DNA sequencing for hereditary cancer predisposition assessment test system (866.6095). All three took effect that day.

Which companies' De Novo requests do the new FDA classification regulations come from?

The three rules codify De Novo grants to HistoSonics for the Edison System (classified October 6, 2023), Masimo for ORi (October 12, 2023), and Invitae for the Common Hereditary Cancers Panel (September 29, 2023).

Why does a new Class II classification regulation matter to a device startup?

Once FDA codifies a device type in a classification regulation, a follow-on sponsor whose device matches the identification language can file a 510(k) against that regulation and its special controls instead of filing its own De Novo request. The three regulations published October 6, 2026 took effect immediately.

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