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

What it does

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.

The Food and Drug Administration's summary, as published in the Federal Register.

What it would change

3 parts of Title 21 of the Code of Federal Regulations:

21 CFR 870, 21 CFR 876, 21 CFR 878

What happens next and when

Either electronic or written comments on the notification must be submitted by October 16, 2026.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2025-N-6224 on Regulations.gov
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register