The U.S. Food and Drug Administration (FDA) has confirmed that computer-aided detection and triage software for radiology still needs a 510(k) before it can be marketed. In a final order published in the Federal Register on September 17, 2026, FDA denied a petition that asked for a partial exemption from premarket notification for these devices.
The petition covered four types of radiology software and proposed that manufacturers who already held a 510(k) clearance could be exempt from submitting a new one. That would have applied to manufacturers with a post-market plan, transparency measures, and training in place. FDA reviewed the petition and the public comments and concluded that it did not show a 510(k) is unnecessary for these devices.
This is not a change to the rules. These devices already required a 510(k), and they still do. For teams preparing an AI radiology 510(k), the order confirms that FDA is not offering a partial exemption for these device types, even to manufacturers that already hold a clearance.
Background: The Petition Behind the Order
Under section 510(k) of the Federal Food, Drug, and Cosmetic Act, a device may not be marketed until FDA finds it substantially equivalent to a legally marketed device that does not require premarket approval. FDA can exempt certain class II devices from this requirement, including in response to a petition.
On October 22, 2025, FDA received a petition asking for a partial exemption for four types of radiology software. It proposed exemption for manufacturers that already held a 510(k) clearance and had a post-market plan, transparency measures, and training in place. Existing special controls, quality system, registration, and listing requirements would have stayed in force.
What the Final Order Decides & Timelines
After reviewing public comments and applying its standard exemption factors, FDA concluded that the petition did not show a 510(k) is unnecessary to assure the safety and effectiveness of these devices. Manufacturers must continue to submit and receive FDA clearance of a 510(k) before marketing these devices.The order covers four device types:
Device type | Category | Regulation |
Radiological computer-assisted diagnostic software for lesions suspicious of cancer | CADx | 21 CFR 892.2060 |
Medical image analyzers | CADe | 21 CFR 892.2070 |
Radiological computer-aided triage and notification software | CADt | 21 CFR 892.2080 |
Radiological computer-assisted detection and diagnosis software | CADe/x | 21 CFR 892.2090 |
FDA received the petition on October 22, 2025, and published a notice of it on December 29, 2025, with comments closing on February 27, 2026. FDA denied the petition by letter on April 1, 2026, and published the final order on September 17, 2026, effective the same day.
Implications for AI and SaMD Developers Specifically
The order applies by classification regulation, not by whether the software uses AI. Many AI radiology tools fall under the four regulations it covers, so they remain on the 510(k) pathway. The order does not describe a new pathway for them.
FDA also noted its longstanding commitment to innovative and least burdensome approaches for software and digital health devices. It said it supports continued consideration of approaches that may speed access to safe and effective devices. The order does not say what those approaches might look like, and FDA did not find that the measures proposed in the petition were enough to remove the 510(k) requirement.
For more on how software fits into FDA’s device framework, see our guide to the SaMD regulatory pathway in Canada and the U.S. and our news post on FDA’s 2026 AI medical device guidance.
What This Means for Your Business
For developers of radiology detection, diagnosis, or triage software, the regulatory path stays the same. The order does not create an exemption for manufacturers that already hold a clearance, so plan on a 510(k) before marketing. A good first step is to confirm which classification regulation applies to your device: 21 CFR 892.2060, 892.2070, 892.2080, or 892.2090. Documenting your intended use early also helps, since it points to the right classification.
Our guides on what to do and avoid in a 510(k) submission and 510(k) pre-submission steps are a helpful starting point for a first submission. Our team also supports software as a medical device projects through our FDA SaMD compliance services.
Frequently Asked Questions
Does this order change anything for AI radiology developers?
No. All four device types already required a 510(k) before the order, and they still do. FDA denied the petition by letter to the petitioner on April 1, 2026. The September 17 order formally publishes that decision as FDA's final determination, as the FD&C Act's petition process calls for. The order keeps the existing 510(k) requirement in place and the partial exemption the petition proposed for manufacturers with a prior clearance is not available. Developers can continue with the same 510(k) pathway they were already following.
Can these devices be marketed without a 510(k)?
No. Manufacturers must submit a 510(k) and receive FDA clearance before marketing these devices, and they must comply with all other applicable requirements under the FD&C Act. The order does not create an exemption for manufacturers that already hold a clearance.
What did the petition ask for, and why did FDA deny it?
The petition asked for a partial exemption for manufacturers with a prior 510(k) clearance, provided they had a post-market plan, transparency, and training measures in place. FDA determined that the information presented did not demonstrate that a 510(k) is unnecessary for these devices. FDA's full response is available in docket FDA-2025-P-5560 on Regulations.gov.
Key Takeaways
- FDA published a final order on September 17, 2026, denying a petition for a partial 510(k) exemption for radiology CAD and CADt software.
- Nothing changes. These devices required a 510(k) before and still do.
- The order covers four device types under 21 CFR 892.2060, 892.2070, 892.2080, and 892.2090.
- It does not create a new exemption pathway.
- Developers should confirm their device’s classification regulation and plan for a 510(k).
Next Steps for Developers
Developers working on radiology detection, diagnosis, or triage software can treat this order as confirmation of the path ahead. The first step is to confirm which of the four classification regulations applies to your device. From there, build your submission plan around a 510(k), including the testing, documentation, and timelines it will need.
Products still in development have the most flexibility. Settling your intended use and classification early makes it easier to plan your evidence and your submission strategy before specifications are locked. If you already have a cleared device, it is also a good moment to check that your records and regulatory documentation are current.
Our team guides medical device companies through FDA medical device compliance, including 510(k) and SaMD submissions. To talk through your product, contact us.
