FDA’s new guidance on general wellness

Yesterday's release by FDA on wellness vs medical device leaves me with a bitter aftertaste. Why?

I'm usually enthusiastic about policies that lower the barrier to market entry for health products. I'm less enthusiastic about those that eliminate the quality drivers from it..

My main concerns under this guidance:

> General wellness products have no QMS requirement, especially digital ones. So when the guidance says you can now display biomarkers even with some disease reference as long as "the product has validated values" for those biomarkers, it doesn't really mean anything. How do they validate? According to what? Where? Claims get bolder and accountability weaker.

> We will see more products being Class IIa medical devices in EU (with QMS auditing and device file review) while facing zero expectations in the US as general wellness.

> The gap between EU and US regulatory approach gets wider. EU released a "similar" guidance in Sep 2025 emphasising the opposite, with increased focus on mechanism of action and technology rather than relying on claims only. US heads the other way, making it all the more complicated for us RA 🥴

> It will be harder for startups to design their product and strategies for the two main western markets simultaneously. They will be pushed even heavier towards wellness-first but in my experience they get easily stuck there.

> This bold approach may be (too) specific of this administration. Will it then outlive it? It is also clearly result from the WHOOP controversy, given the number of references to Blood Pressure measuring wrist-worn devices. Pretty solid legal and lobby teams there.

One example that puzzles me in particular is the one about glucose monitoring via "minimally invasive microneedle technology" for which FDA says they will apply enforcement discretion as a low risk device. Since I'm currently working on the biocompatibility testing requirements for a device that is hand held by doctors using gloves (👀), I cannot help but finding it unfair towards the rest of the sector.

So I hope you will excuse my slightly less upbeat post this time.

I'm generally excited about the expansion of the definition and agree with the rationale of most of the examples provided.

I'm curious to see what it will mean for international harmonisation and for the opportunities it will open for my clients at this interface!