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    • MEDICAL DEVICES—FINAL RULES: Classification of the infant pulse rate, oxygen saturation monitor for OTC use
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    • MEDICAL DEVICES—FINAL RULES: Classification of the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens
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    Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: Classification of the infant pulse rate, oxygen saturation monitor for OTC use, (Oct 14, 2026)

    By WK Editorial Staff

    The FDA identified the risks to health associated with this type of device and the measures required to mitigate these risks.

    The FDA has classified the infant pulse rate and oxygen saturation monitor for over-the-counter use into class II (special co ...

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