Over the last year, I’ve had more conversations that start with some version of: “What is FDA actually doing right now?”
The answer is complicated.
The agency is still reviewing submissions. Still clearing devices. Still conducting inspections. But many of the traditional mechanisms industry relies on to understand FDA’s thinking—guidance updates, public communication, interpretive clarity—have become noticeably less stable.
In this clip from a recent webinar discussion, we talk through what that looks like in practice:
de novos with placeholder regulations,
AI-assisted review tools like ELSA,
delayed guidance modernization,
QMSR implementation pressures,
and the growing need for companies to interpret FDA behavior in real time rather than rely solely on published documentation.
There’s also a broader question underneath all of this: what happens when regulatory systems continue functioning operationally while becoming less transparent interpretively?
That’s where things start getting interesting.
