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    • MEDICAL DEVICES—FINAL RULES: Certain Class II clinical toxicology test systems exempted from premarket notification
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    • MEDICAL DEVICES—FINAL RULES: Classification of the focused ultrasound system for non-thermal, mechanical tissue ablation
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    Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: Classification of the focused ultrasound system for non-thermal, mechanical tissue ablation, (Oct 7, 2026)

    By WK Editorial Staff

    The FDA undertook its action because it determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device.

    The FDA classified the focused ultrasound system for non-thermal, mechanica ...

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