FDA published three final device classification orders in the November 5 Federal Register. The new types are the wearable vibration device for orthopedic use at 21 CFR 888.5895, product code QZO; the prognostic assessment software of mild cognitive impairment at 21 CFR 882.1454, product code QWT; and the digital cervical cytology slide imaging system with an artificial intelligence algorithm at 21 CFR 864.3900, product code QYV. All three are Class II with special controls.
Each order traces back to a De Novo granted in January 2024. QZO comes from the Osteoboost Belt, DEN230015, granted to Bone Health Technologies on January 12. QWT comes from Darmiyan's BrainSee, DEN220066, granted January 11. QYV comes from Hologic's digital cytology system, DEN210035, granted January 31.
Codification is the step that turns a granted De Novo into a usable predicate, so a follow-on can file a 510(k) rather than run its own De Novo. The special controls decide how cheap that is. The Osteoboost order requires clinical performance testing with at least a year of follow-up on bone strength and bone mineral density, which sets the real cost for a second entrant.
Questions & Answers
Which device types did FDA classify in the November 5, 2026 Federal Register?
FDA created three Class II device types: the wearable vibration device for orthopedic use (21 CFR 888.5895, product code QZO), the prognostic assessment software of mild cognitive impairment (21 CFR 882.1454, product code QWT), and the digital cervical cytology slide imaging system with an artificial intelligence algorithm (21 CFR 864.3900, product code QYV).
Which De Novo requests do the new FDA device classifications come from?
All three come from De Novos granted in January 2024: Bone Health Technologies' Osteoboost Belt (DEN230015, January 12), Darmiyan's BrainSee (DEN220066, January 11) and Hologic's digital cervical cytology system (DEN210035, January 31).
Why does codifying a De Novo matter for a medical device startup?
Once FDA writes a De Novo into the CFR with special controls and a product code, the granted device becomes an available predicate, so a later company can file a 510(k) instead of its own De Novo. It still has to meet the special controls, which for the wearable vibration type include clinical performance testing with at least one year of follow-up.