SILVER SPRING, MD – Software that reads your medical scan and flags what it finds must still pass an FDA check before it is sold.
The agency put that on the public record on Thursday. A company had asked for the check to be dropped in certain cases, and the answer was no.
The order is dated 17 September 2026 and took effect the same day. Its title is easy to misread: “Exemption From Premarket Notification”. It is the record of an exemption refused.
Contents
What this software actually does#
Four kinds of program are covered, and none of them is exotic.
One is diagnostic software for lesions that may be cancer. One is a medical image analyzer. One is triage and notification software. The order names it and does not say what the notification is for. The fourth both detects and diagnoses.
Each has its own section in the regulations. Between them they carry six product codes, because two of the four categories hold two each.
They sit behind ordinary radiology. The order names no scan and no body part, beyond saying the first category covers lesions suspicious of cancer.
The check they were asking to skip is called premarket notification, or 510(k). The order explains what it does in one line.
“The device may not be marketed until FDA finds it ‘substantially equivalent’ …”
The order does not spell out what those two words mean. It points at section 513(i) of the law and leaves the test there.
The rest of the sentence limits the comparison. It must be equivalent to “a legally marketed device that does not require premarket approval”.
So the yardstick is another product already sold that did not itself need the stricter approval route.
The order is blunt that all four categories carry that duty today.
“All these devices currently require premarket notification under section 510(k) of the FD&C Act.”
What was asked, and by whom#
The petition came in on 22 October 2025. It was filed by Nancy Stade of Rubrum Advising, on behalf of a company called Harrison.ai.
It is on the public record under the public docket FDA-2025-P-5560.
It did not ask for the check to vanish. It asked for it to stop repeating.
The central condition was that the manufacturer already held a 510(k) clearance.
For triage software, that earlier clearance had to sit under the same regulation. For the other three categories it could sit under any of those three.
The petition offered things in return. A post-market plan, transparency measures and training. And it left the existing special controls, quality systems and registration duties in place.
This is worth being fair about. It asked to reduce a repeated burden on companies that had already been through the process once. It did not ask to remove oversight.
The public was asked. The agency published notice of the petition on 29 December 2025 and took comments until 27 February 2026.
Why the agency said no#
The answer went to the petitioner by letter on 1 April 2026.
“FDA denied the petition in a response issued to the petitioner on April 1, 2026.”
The stated reason is narrow and it is about evidence rather than principle.
“FDA determined that the information presented in the petition does not demonstrate that premarket notification is not necessary …”
What the ellipsis holds is the legal test. It asks whether the check is necessary “to assure the safety and effectiveness” of the devices the petition covered.
Read that carefully, because the double negative hides the point. The agency did not rule that the check is always necessary. It ruled that this petition did not show it was unnecessary.
There is a published list of what would have shown that. The first item asks about a significant history of two things. False or misleading claims, or risks built into what the device is.
The order does not say which of those tests the petition failed, or by how much. That silence is real and this page will not fill it.
And the order as published ends by leaving the door open.
“FDA supports the continued consideration of innovative and least burdensome approaches that may accelerate the availability of safe and effective devices.”
The five months, measured against the order’s own deadline#
The decision was made on 1 April. The public order appeared on 17 September.
More than five months sat between the two, and the order does not say why.
There is a rule about this, and the order quotes it. It starts once the agency publishes notice of a petition.
“Within 120 days after the issuance of the notice, FDA must publish an order in the Federal Register that sets forth its final determination …”
The notice was published on 29 December 2025. One hundred and twenty days after that is 28 April 2026.
This order was published on 17 September 2026. That is 142 days later than the date the quoted rule points to.
The other deadline was met. The law gave the agency 180 days from the petition to answer, and the order says it denied the petition “within the 180-day timeframe”.
So the answer was inside its window and the public record was not. The order never sets its own publication date against the 120 day rule, and this page will not guess at a reason. A rule you cannot see is a rule you cannot check, and checking one is a skill.
What it does not say, and what happens next#
It gives no count of how many products or companies are affected. The order names four categories and no population, and this page will not estimate one.
It says nothing about what the petitioner may do now. There is no path to re-petition set out and no future review date named.
And it changes nothing about how these products work in a hospital today. The check that existed last week exists this week. The news is that an attempt to shorten it did not succeed.
For a patient the practical position is simple. The software that reads your scan is a regulated product, and the company behind it had to satisfy the agency before selling it.
That last part is the part somebody asked to change.
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Source: Federal Register 2026-19074, 91 FR 58817, published 17 September 2026, full text read; and the public docket FDA-2025-P-5560.