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Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA) is announcing its intent to exempt from premarket notification requirements certain class II clinical toxicology test system devices. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devices included in this document. FDA will review any comments submitted within the 60-day comment period and will further consider whether the exemption described in this notice should be modified prior to publication of its final determination in the Federal Register.
- Document type
- Notice
- Federal Register document number
- 2026-08499
- Published
- May 1, 2026
- Action
- Notice; request for comments.
- Docket
- FDA-2026-N-4268
- Comments posted on Regulations.gov (at last check)
- 70
- DATES section (from the document)
- Either electronic or written comments on the notice must be submitted by June 30, 2026.
- Topics (auto-tagged)
- Medical devices
Source: Federal Register API, document 2026-08499. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.