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

**Action Urgency Score:** 20/100

| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Proposed rule |
| Action | Notification; request for comments. |
| Published | 2026-08-17 |
| Comments close | 2026-10-16 |
| Significant | No |
| CFR parts | 21 CFR 870, 21 CFR 876, 21 CFR 878 |
| Summary | 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 respe |
| Document number | 2026-16729 |

## Why this score


Source: Federal Register API (Office of the Federal Register) (https://www.federalregister.gov/documents/2026/08/17/2026-16729/medical-devices-classification-of-accessories-distinct-from-other-devices-proposed-list-of). Last refreshed: 2026-11-04T21:40:49.974Z.
Data from the Federal Register API; the published Federal Register document is authoritative. Informational only, not legal advice.