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Open for comment Health and Human Services Department, Food and Drug Administration Docket Docket No. FDA-2025-N-6224

FDA proposes Class I classification for specific medical device accessories under FDARA

💬 Comments close in 59 days (Oct 16)

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Timeline

  1. Proposed / opened

    FDA proposes Class I classification for specific medical device accessories under FDARA

  2. Related document

    Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments

Briefs in this proceeding

Notable FDA 💬 Comments close in 59 days (Oct 16)

FDA proposes Class I classification for specific medical device accessories under FDARA

FDA seeks comment on classifying certain accessories as Class I devices, where general controls alone would ensure safety and effectiveness. The Food and Drug Administration (FDA) has published a proposed list of medical device accessories that it believes should be classified as Class I devices...

Sources

Health and Human Services Department, Food and Drug Administration · Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments · Aug 17