美国FDA持续兑现十年前承诺 对低风险器械的监管再次减负
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2026年6月，美国FDA对外宣布，拟对另外五种未分类医疗器械豁免上市前通知（510(k)）的要求。这一举措通过更新一份名为《拟豁免某些未分类医疗器械的上市前通知要求》
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Unclassified 510k PMA Contact ODE 510K Exempt HDE-Humanitarian Device Exemption Enforcement Discretion EUA-Emergency Use Authorization
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