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Product safetyFDAUnited StatesImports

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

6 October 2026

In plain English

FDA has finalized an order exempting certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to stated limitations, effective immediately.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
6 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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
The full text is at the source

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