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FDA’s September 10, 2026 ENT order codified a 2023 decision
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Framework effective Sep 10, 2026 · Published Oct 15, 2026.
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FDA final order: cooperative powered surgical-assist device for ENT surgery, 91 FR 57502–57504 ↗eCFR section 874.4460 observed October 6, 2026; Title 21 displayed current through October 2 ↗FDA De Novo record DEN220047, observed October 6, 2026 ↗FDA Galen ES De Novo classification order and indication, July 19, 2023 ↗FDA product classification QXG, observed October 6, 2026 ↗Downloads match this version of the reporting. If a story changes, reopen its kit for current copy and graphics. A previously downloaded file cannot be recalled.
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