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

The record

Publisher

Federal Register

Agency

Health and Human Services Department; Food and Drug Administration

Source

Federal Register

Kind

Federal Register: final rule

Jurisdiction

United States

Topics

Health

Importance

Notable, the middle of three tiers Kresmion sets by fixed rules from the source's own fields

Published (source time)

2026-09-17 (the source gives a date only)

First seen on Kresmion

2026-10-26 18:24 UTC

The original

• PDF (Federal Register)

Source: Federal Register (federalregister.gov). U.S. government work, public domain.

The publisher's summary

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).

The publisher's words, as published.

Federal Register document

Document number

2026-19074

Document type

Rule

Status

Published