Data / Federal rules / 2026-19074
Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
The Food and Drug Administration published this final rule in the Federal Register on September 17, 2026. It took effect on September 17, 2026.
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What the agency says
The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer- aided detection and/or diagnosis devices and computer-aided triage and notification devices that was the subject of a notice published in the Federal Register of December 29, 2025. That notice announced FDA's receipt of a petition that requested exemption from the premarket notification requirements for the following generic device types when certain conditions described in the petition were met: radiological computer-assisted diagnostic software for lesions suspicious of cancer; medical image analyzers; radiological computer aided triage and notification software; and radiological computer-assisted detection and diagnosis software. FDA denied the petition in a response issued to the petitioner on April 1, 2026. FDA is publishing this order in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Key facts
- Document number
- 2026-19074
- Type
- Final rule
- Action
- Final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 17, 2026
- Takes effect
- September 17, 2026
- Dates
- This order is effective September 17, 2026.
- Docket
- Docket No. FDA-2025-P-5560
- Code of Federal Regulations
- 21 CFR 892
- Pages
- 3
Other documents from the Food and Drug Administration
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Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.