Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
The Food and Drug Administration (FDA) has published a document proposing to classify a list of medical device accessories as Class I, distinct from other devices. As required by the FDA Reauthorization Act of 2017 (FDARA), the agency believes general controls alone provide reasonable assurance of safety and effectiveness for these items. The FDA is currently seeking public comments, and this proposal does not represent a final determination.
Original source: Federal Register — FDA Documents — 2026-08-17T04:00:00+00:00
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