# 2026-12166: FDA Eases Path for AI Radiology Tools

2026-12166, Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-06-17, effective 2026-06-17; PRIA reads it as touching household money (as of 2026-06-24).

- Canonical: https://policyrisk.com/federal-register/2026-12166
- As of: 2026-06-24
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12166
- Title: Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 36522
- Published: 2026-06-17
- Effective: 2026-06-17
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-06-24

## In one line

FDA Eases Path for AI Radiology Tools

## Summary

The FDA is officially putting radiology software that uses machine learning and has a set plan for updates into a safer, easier-to-manage category called Class II. This change helps make sure the software is safe and effective while speeding up patient access to cool new tech. It’s been effective since early 2023, so companies can expect fewer hoops to jump through without extra costs or delays.

## Abstract

The Food and Drug Administration (FDA) is classifying the radiological machine learning-based quantitative imaging software with predetermined change control plan into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the radiological machine learning-based quantitative imaging software with predetermined change control plan. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

## Effects PRIA read

- Radiology ML Software Now Class II: benefit, medium. The FDA has classified radiological machine learning-based quantitative imaging software with a predetermined change control plan as Class II (special controls). The order is effective June 17, 2026, and the classification has been applicable since February 24, 2023.
- Creates Predicate for Future Devices: benefit, medium. Because FDA classified this device type via the De Novo process, the device can serve as a predicate for future devices of that type. That lets other device sponsors use the less burdensome 510(k) process instead of submitting a De Novo request or a premarket approval application.
- Premarket 510(k) Notification Required: cost, medium. The rule states that this device type is subject to premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act unless FDA later exempts it under section 510(m).
- New Technical and Labeling Requirements: mixed, medium. The final order establishes special controls including: detailed design verification and validation (algorithm descriptions, training data details, independent test datasets, objective performance measures), documentation of planned modifications under the predetermined change control plan (PCCP),…

## Related documents

- [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11
- [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13
- [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29
- [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25
- [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27
- [2026-20727](https://policyrisk.com/federal-register/2026-20727): Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorgani…, 2026-10-09

## Sources
- [2026-12166 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/17/2026-12166/medical-devices-radiology-devices-classification-of-the-radiological-machine-learning-based)
- [2026-12166 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-17/pdf/2026-12166.pdf)

## Related
- [Previous: 2026-12165, Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingest…](https://policyrisk.com/federal-register/2026-12165)
- [Next: 2026-12168, Security Zone; FIFA World Cup and Fan Fest 2026, Bayfront Park, Miami, FL](https://policyrisk.com/federal-register/2026-12168)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-12166 (as of 2026-06-24).