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Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
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Summary (from the Federal Register abstract)
As required by the FDA Reauthorization Act of 2017 (FDARA), the Food and Drug Administration (FDA or Agency) has identified a list of accessories for which the Agency believes general controls alone are sufficient to provide reasonable assurance of safety and effectiveness, making them appropriate for class I classification. FDA is publishing this document proposing to classify these accessories into class I and distinct from other devices, as well as seeking public comment in accordance with procedures established by FDARA. This document does not represent FDA's final determination with respect to the proposed accessories listed in this document.
- Document type
- Proposed Rule
- Federal Register document number
- 2026-16729
- Published
- Aug 17, 2026
- Action
- Notification; request for comments.
- Docket
- FDA-2025-N-6224
- Comments posted on Regulations.gov (at last check)
- 9
- CFR parts
- 21 CFR 870, 21 CFR 876, 21 CFR 878
- DATES section (from the document)
- Either electronic or written comments on the notification must be submitted by October 16, 2026.
- Topics (auto-tagged)
- Medical devices
Source: Federal Register API, document 2026-16729. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.