Regulatory Deadline Board/2026-16729
Food and Drug Administration · Proposed Rule
Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
Closed 13 days ago
In plain English
FDA proposed a list of device accessories it believes can move to class I under general controls alone, as required by FDARA.
Who it hits
Accessory makers, OEMs bundling accessories with parent devices, and 510(k) consultants.
- Agency
- Food and Drug Administration
- Document type
- Proposed Rule
- Published
- Aug 17, 2026
- Comments close
- Oct 16, 2026
- Status
- Closed 13 days ago
- Federal Register number
- 2026-16729
- Docket
- Docket No. FDA-2025-N-6224
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