An FDA order that changes who can compete in a cancer-test category takes effect on September 16. Fewer than five people commented on it. The comment period closed in August of last year, and everyone who wrote in was in favor.
The order is Federal Register 2026-16727, published August 17. It covers in situ hybridization test systems indicated for use with an approved oncology drug. These are the probe-based assays that tell an oncologist whether a tumor carries the genetic change a particular drug goes after. The order moves them out of Class III and into Class II. Four product codes are affected: NYQ, MVD, OWE and PNK. A company bringing one of these tests to market no longer files a PMA. It files a 510(k) against a new regulation, 21 CFR 864.1890.
If you already hold one of those PMAs, nothing happens to you on September 16. FDA says approved devices may keep marketing under the approval already issued, with no additional authorization required. Changes that could affect safety or effectiveness now go in as a 510(k) instead of a PMA supplement.
FDA built the new door out of the incumbents' data
FDA points to the PMA data already sitting in its files, to published literature on what it calls a longstanding and well-understood technology, and to these tests not having thrown significant postmarket safety signals. The agency expects the change to cut regulatory burden, shorten review, and bring more manufacturers into the category. The incumbents built that record to get through Class III. FDA used it to decide Class III was no longer necessary.
I've been through a version of this from the other side. At Galen we were routed to a de novo, and near the end of the process FDA asked us what the new regulation describing our device ought to say. We conferred, wrote a paragraph, and sent it in. The regulation came back word for word what we had submitted. We set the standard the category had to match, and we knew the exact sentence we'd set it with, which is the part the ISH order takes away: the incumbents here didn't get to pick the words.
Class II here is not a shortcut
The new regulation carries nine design verification and validation special controls, and they're specific. Analytical sensitivity against normal karyotype specimens. Analytical specificity covering probe specificity, interference and cross-reactivity. Precision across multiple reagent lots, operators, instruments, sites and reader assessments, with data near the clinical thresholds. Robustness across the tolerance ranges of critical test parameters. Linearity. Specimen stability. Clinical performance in specimens from the intended population. Three labeling controls sit on top of that.
So the evidence burden didn't go anywhere, it moved. A company used to work that burden out privately with a reviewer over the course of a PMA. Now any competitor can pull up 21 CFR 864.1890, read the list, and cost it out before deciding whether to enter.
The docket ran for fifteen months
FDA proposed the change in June 2025. Comments closed that August, the final order landed a year after that, and it takes effect thirty days later. Fifteen months of public notice, and fewer than five people commented on a rule resetting the entry cost for a whole class of oncology tests. Most of the few who did comment came from device companies themselves.
Fifteen months of notice is the part worth carrying into other categories, because the pattern travels. Any company whose competitive story leans on a regulatory approval is exposed to the same move, and the warning shows up in a docket months before it shows up anywhere a founder is looking. The product codes covering your device are public. Every proposed rule that touches them is published before it takes effect.
Dave's take
When I argue that a de novo makes you the predicate, I've always attached a condition to it: the predicate position holds until the category gets crowded enough that defending the standard costs more than it returns. This rule is a faster route to that same crowding. FDA didn't wait for fast followers to show up, it opened the door itself, and it used the incumbents' own submissions as the reason. If your plan for years three through six assumes the pathway you walked is the pathway your competitors will have to walk, that assumption belongs on your risk register.
From Dave’s video library
Dave checks a claimed time-saving number for AI scribes against the study behind it, and finds the measured result is far smaller than the claim.
I’m here to help you scale.
Work With DavePrefer a smaller first step? Book a $500 one-hour working session →
Dave Saunders is the founder of Base Reality Group and a Fractional CPO for product companies. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →