# \#医疗器械附件

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## [2026-08-17【FDA】拟将一批医疗器械附件独立划为 Class I，并豁免 510(k)](https://witpoise.club/t/topic/206)

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**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年8 月 18 日 12:41 UTC](https://witpoise.club/t/topic/206 "2026-08-18T12:41:00Z")

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原文链接：Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable …