Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems

The record

Publisher

Federal Register

Agency

Health and Human Services Department; Food and Drug Administration

Source

Federal Register

Kind

Federal Register: final 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)

2026-10-06 (the source gives a date only)

First seen on Kresmion

2026-10-26 18:25 UTC

The original

• PDF (Federal Register)

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

The publisher's summary

The Food and Drug Administration (FDA) is publishing an order setting forth its final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k) requirements, subject to certain limitations, is immediately in effect for such devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is amending the classification language within the Code of Federal Regulations (CFR) for certain class II clinical toxicology test systems to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The publisher's words, as published.

Federal Register document

Document number

2026-20448

Document type

Rule

Status

Published