The companion diagnostic list changed its name

FDA’s page pairing an in vitro diagnostic with the therapeutic product it enables carries a name today it did not carry two months ago. The current title reads List of FDA-Authorized Companion Diagnostic Devices (In Vitro and Imaging Tools). Its predecessor, in place for more than a decade, read List of Cleared or Approved Companion Diagnostic Devices— the same subject, described by exactly two possible outcomes.

Two outcomes, then four

“Cleared” and “approved” are 510(k) and PMA, and for most of the list’s life those were the only two doors an in vitro companion diagnostic walked through to reach it. FDA’s 2014 final guidance, In Vitro Companion Diagnostic Devices, set the expectation still governing the pairing: in most circumstances, a companion diagnostic and the therapeutic product it accompanies should reach the market contemporaneously, reviewed side by side rather than one waiting on the other. The guidance never restricted which premarket pathway the diagnostic itself had to travel — only PMA and 510(k) were the active choices when its language settled into practice.

As of this July, the same table also carries entries authorized by De Novo classification and by Humanitarian Device Exemption. Neither pathway is new to device regulation. What changed is that a companion diagnostic can now travel either one and still land on a list built, and titled, around a binary FDA had already left behind.

The rename is the finding

A page that keeps its old name after its own contents outgrow it is the more common failure. This one renamed itself on time — which means the two-outcome mental model this table trained for a decade is the thing that’s now wrong, not the page.

Reading the current list for a competitor’s device, or your own, “on the list” no longer answers which review standard the diagnostic met. A PMA-approved entry cleared FDA’s most demanding premarket standard; a De Novo entry created a new classification because no predicate existed to clear against; an HDE entry was never held to the same effectiveness finding a PMA requires at all. The pathway column, not the presence of a row, is where that answer lives now.

Not in the corpus this pipeline reads

This table is a manually maintained CDRH web page, not a structured API endpoint. It sits outside what FDA Radar currently monitors, the same way the Recognized Consensus Standards list and the pending-submission gap do — a real FDA record this product does not automatically ingest, so a portfolio’s companion-diagnostic status is not something a match here will ever surface on its own. Reading the table correctly, for a specific device and a specific competitor, is a judgment for a regulatory professional working from the primary source directly. This is regulatory intelligence and method, never regulatory advice about what a specific pairing on that list means for a specific submission.