FDA Classifies AI Radiology Tools for Safer Innovation
Published Date: 6/13/2025
Rule
Summary
The FDA is officially putting radiology computer-assisted detection and diagnosis software into a special safety group called Class II. This means the software will have clear safety rules to follow, making it safer and easier for patients to get new, helpful tech. Companies making this software should get ready for these changes, which aim to speed up innovation without extra costs or delays.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Radiology AI Moved to Class II
If you get radiology tests that use computer-assisted detection and diagnosis software, the FDA is officially placing that software into Class II with special safety controls. The FDA says this classification provides a reasonable assurance of safety and effectiveness and should help patients get safe, innovative devices.
New Special Controls for Makers
If you make radiological computer-assisted detection and diagnosis software, the FDA will codify special controls for that device type under Class II. The agency says the action is intended to reduce regulatory burdens and enhance innovation and patient access, so manufacturers should prepare to follow the new codified controls.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-16939, GNT USA, LLC.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
2026-16944, Gardenia Blue Interest Group; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG or petitioner), c/o Exponent, Inc., proposing that we amend our color additive regulations to expand the safe use of gardenia (genipin) blue in various foods at levels consistent with good manufacturing practice. The petition also proposes to lower the specification for arsenic in gardenia (genipin) blue.
Previous / Next Documents
Previous: 2025-10788, Medical Devices; Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry Microorganism Identification and Differentiation System
The FDA is officially putting a new type of medical device, called the clinical mass spectrometry microorganism identification and differentiation system, into a special safety category called Class II. This means the device will have clear safety rules to follow, making sure it works well and is safe for patients. This change helps companies bring these cool, innovative tools to doctors faster without extra red tape.
Next: 2025-10812, Significant New Use Rules on Certain Chemical Substances (23-3.5e)
The EPA is setting new rules for certain chemicals, making sure anyone who wants to make or use them in new ways tells the EPA 90 days ahead. This gives the EPA time to check if the new use is safe before it starts. If you work with these chemicals, get ready to follow these steps to keep things safe and legal!