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

The record

Publisher

Federal Register

Agency

Health and Human Services Department; Food and Drug Administration

Source

Federal Register

Kind

Federal Register: proposed rule

Jurisdiction

United States

Topics

Health

Importance

Notable, the middle of three tiers Kresmion sets by fixed rules from the source's own fields

Published (source time)

2026-08-17 (the source gives a date only)

First seen on Kresmion

2026-10-26 18:24 UTC

The original

• PDF (Federal Register)

Source: Federal Register (federalregister.gov). U.S. government work, public domain.

The publisher's 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 respect to the proposed accessories listed in this document.

The publisher's words, as published.

Federal Register document

Document number

2026-16729

Document type

Proposed Rule

Status

Published