Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
Built by the Tribune's code from the Federal Register. No AI wrote this page. Published in the Federal Register Sept. 17, 2026. Document 2026-19074. Updated Nov. 5, 2026.
- What it does
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 Food and Drug Administration's summary, as published in the Federal Register.
- What changed in the regulation
1 part of Title 21 of the Code of Federal Regulations:
Wording on eCFR: the day before it took effect and from the day it took effect (first part listed).
- Compared with
The Food and Drug Administration has published 100 final rules in 2026 so far, compared with 68 in all of 2025.
Counted by the Tribune from Federal Register records since Jan. 1, 2025.
- What happens next and when
This order is effective September 17, 2026.
The agency's dates, word for word.
The record as published
| Document number | 2026-19074 |
|---|---|
| Action | Final order. |
| Agencies | Health and Human Services Department; Food and Drug Administration |
| Published | Sept. 17, 2026 |
| Effective date | Sept. 17, 2026 |
| Docket | FDA-2025-P-5560 |
Source: the Federal Register (public domain). The document in the Federal Register