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

**Action Urgency Score:** 30/100

| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Final rule |
| Action | Final order. |
| Published | 2026-09-17 |
| Effective | 2026-09-17 |
| Significant | No |
| CFR parts | 21 CFR 892 |
| 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: r |
| Document number | 2026-19074 |

## Why this score
- Final rule.

Source: Federal Register API (Office of the Federal Register) (https://www.federalregister.gov/documents/2026/09/17/2026-19074/medical-devices-exemption-from-premarket-notification-radiology-computer-aided-detection-andor). Last refreshed: 2026-11-03T19:10:06.902Z.
Data from the Federal Register API; the published Federal Register document is authoritative. Informational only, not legal advice.