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

What it does

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

What changed in the regulation

1 part of Title 21 of the Code of Federal Regulations:

21 CFR 862

Wording on eCFR: the day before it took effect and from the day it took effect (first part listed).

Compared with

The Food and Drug Administration has published 100 final rules in 2026 so far, compared with 68 in all of 2025.

Counted by the Tribune from Federal Register records since Jan. 1, 2025.

What happens next and when

This order is effective October 6, 2026.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2026-N-4268 on Regulations.gov
• Title 21 on eCFR

The record as published

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