FDA: radiology AI still needs a 510(k), including follow-on devices

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What happened: On 17 September 2026, the US Food and Drug Administration (FDA) published its final decision in the Federal Register. Radiology AI software for detection, diagnosis and triage will not get a partial exemption from 510(k) requirements. A 510(k), or premarket notification, is the submission in which a manufacturer shows that its device is substantially equivalent to a device already on the market (the “predicate”). The petition had asked that manufacturers with at least one existing clearance be allowed to market further devices of the same type without a new 510(k), in return for commitments on postmarket monitoring and user training. FDA had already denied this to the petitioner on 1 April 2026. The decision covers the device types in 21 CFR 892.2060 to 892.2090.

The problem: Anyone planning a portfolio of several radiology algorithms cannot count on things getting faster after the first clearance. Each new device still needs its own submission with a predicate and a substantial equivalence argument. Timelines and budgets that assumed an exemption no longer hold.

What manufacturers can do:

1. Review the portfolio plan: Budget a separate 510(k) for every planned device, with buffers for time and cost.
2. Settle on predicates early: Build the predicate search and the comparison table of equivalence characteristics in a structured way before development is finished. AI-assisted search can help here, but review and decisions stay with people.
3. Get changes authorised in advance: Planned model updates belong in the first submission as a Predetermined Change Control Plan (PCCP), a pre-authorised plan for future modifications. FDA has final guidance on PCCPs. With one in place, not every improvement triggers a new submission. A PCCP covers changes to the same device. It does not replace a 510(k) for a new one.
4. Build postmarket monitoring anyway: The measures offered in the petition (postmarket monitoring, transparency, training) generate evidence for future submissions even without an exemption.

Context: In the same notice, FDA says it will continue to explore “innovative and least burdensome approaches” for software. It does not name a concrete alternative to the exemption.

Source: Medical Devices; Exemption From Premarket Notification: Radiology CAD and CADt Devices (FDA, Federal Register), of 17 Sept 2026