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Product safetyFDAUnited StatesImports

Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices

17 September 2026

In plain English

FDA issued a final order granting a partial exemption from premarket notification requirements for radiology computer-aided detection and/or diagnosis devices and computer-aided triage and notification devices.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
17 September 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 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 requiremen
The full text is at the source

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