Data / Federal rules / 2026-16729
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 published this proposed rule in the Federal Register on August 17, 2026. Comments closed on October 16, 2026.
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What the agency says
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.
Key facts
- Document number
- 2026-16729
- Type
- Proposed rule
- Action
- Notification; request for comments
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- August 17, 2026
- Comments due
- October 16, 2026
- Dates
- Either electronic or written comments on the notification must be submitted by October 16, 2026.
- Docket
- Docket No. FDA-2025-N-6224
- Code of Federal Regulations
- 21 CFR 870; 21 CFR 876; 21 CFR 878
- Pages
- 5
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Published in August 2026
Read from the Federal Register API, last updated 2026-10-24. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.