Classification Change is not one event

FDA Radar’s Federal Register ingestion sorts every device-relevant document into one of five categories, and the rule for one of them is a pair of phrases in a title: “classification of” and “reclassification.” Either one earns the same label — Classification Change — and that label alone does not say which kind of event just happened, because the two phrases point at genuinely different things.

Two different orders, one matching rule

The categorizer is deliberately mechanical: a title match, not a judgment call, so a mis-categorized item is a fact FDA Radar got wrong, not a reading it drafted. That mechanism is exactly why it cannot distinguish a reclassification order, which changes the regulatory class an existing product code already sits under, from a De Novo grant order, which creates a product code that did not exist the day before. Both kinds of titles run “[Device area]; Classification of…” or “[Device area]; Reclassification of…”, and both land in the same bucket.

A reclassification order rewrites the rule under a code that already has a history. A De Novo order writes the first page.

What a reclassification order actually changes

21 CFR 860.134 lets the Commissioner reclassify a postamendments Class III device to Class II or Class I by administrative order — on FDA’s own initiative, not only in response to a petition — after publishing a proposed order and taking comment. FDA reclassified non-invasive bone growth stimulators from Class III to Class II this way, by a final order effective May 18, 2026. A proposed reclassification of digital breast tomosynthesis systems, with comments due October 9, 2026, is sitting in the same “Classification Change” bucket right now — a comment opportunity, not yet a rule, filed identically to an order that already binds every device under its code.

What a De Novo grant changes instead

A De Novo grant order does not touch an existing code’s class. It creates the code, the regulation number, and the classification itself, for a device with no predicate to argue equivalence against — FDA granted one for a diabetes digital behavioral therapeutic device in July 2026, the first entry under a code that had no history a month before this post. Nothing about that device’s classification is changing; it is arriving for the first time. The title convention that puts it next to a reclassification order in the same category is a coincidence of phrasing, not a family resemblance in what either document does.

The practice

A “Classification Change” item is worth opening before assuming which of three things it is: a final reclassification, binding today, that changes what every existing device under a familiar code has to meet; a proposed reclassification, worth a comment if it affects a portfolio, but not yet a rule; or a De Novo grant, which starts a code’s history rather than editing it. The category earns the item a place in the queue. Which of the three it is — and what that means for a specific product code — is a reading of the document itself, the kind of judgment this record supports and never replaces.