If you’ve been watching the FDA lately, you might feel like you’re watching a daytime soap opera rather than a regulatory agency. Between hiring freezes, regulation purges, an AI tool named ELSA and the sudden, strange and unexplained disappearance of the ReDI conference, it’s enough to make anyone following the ongoing saga of medical device regulation reach for a strong cocktail. Or two.
But fear not, medical device peeps – we’re going to try to make sense of it all and hopefully make you laugh in the process.
The Snowball Effect of Deregulation
As you have no doubt heard, the new administration kicked off 2025 with an executive order that froze all pending regulations and imposed a “10-for-1” rule — for every new regulation, ten have to be revoked. Then they added a workforce “optimization” policy requiring four terminations for every new hire, creating a perfect storm of confusion (and overwhelming those left in the FDA trenches).
For now, FDA’s starting their deregulation overhaul with food, then drugs, and eventually medical devices. The goal? “Lower cost and empower providers.” The irony? While the FDA works to reduce costs, they are also increasing fees to over $11,000 for annual registration. Not a bad business model if you can get away with it.
But here’s where it gets weird: FDA is still granting de novos but can’t issue the regulation numbers that usually accompany them. So, while you can still get a de novo submission cleared, no one else can use it as a predicate. Anyone doing a search for your device in the FDA databases will be presented with “no results found” – a sneaky competitive advantage if you’re the lucky holder.
Communication Meltdown
After these massive layoffs, FDA’s communications and media teams are practically nonexistent. No press releases, no email updates, no “new guidance” alerts, leaving consultants and regulatory staffers to find out about major changes from LinkedIn posts. On the flip side, the agency asked the public to help decide which regulations and guidance documents to scrap (yes, you read that correctly). In theory, this was democratic, but in practice, it was a paperwork nightmare — a maze of forms so tedious even seasoned consultants can’t finish a submission. And since every comment is public, some companies started arguing in the comments section like it’s Reddit for regulators, something we’ve never seen in our 30+ years of experience in medical device regulation.
Our advice? Check the FDA guidance document database yourself — and often – and don’t take what you may see on LinkedIn (or Reddit) as truth.
When the Government Shuts Down, the Machines Will Rise
As of October 1, the government shutdown means FDA can’t take new submissions or fees of any kind. If you already submitted or paid your fees in FY25, you’re in luck — your submission will proceed. But anyone waiting for October to save a few bucks? You’re in limbo, because the FDA can’t accept your money, as unbelievable as that seems.
They’re also testing “Predict,” a system for customs compliance, and touting big wins like “unleashing cell and gene therapies” and “ending the 70-year war on consuming natural fats.” (Yes, that’s a real quote. I kid you not.)
You just can’t make this stuff up.
But despite the chaos, there are some bright spots. FDA’s AI tool ELSA has been quietly at work for a while, spotting patterns in submissions and even flagging falsified test data. The agency also launched FDA Direct, its very own podcast, complete with hilariously bad word-for-word auto-transcripts.
However, despite it all, the long-awaited transition from QSR to QMSR is still on for February 2026 — and no, it’s not being delayed. FDA’s been updating systems and training staff, even as communications crumble. The short version? Prepare for ISO 13485 alignment, a lot of cross-referencing, and possibly a “death by a thousand paper cuts” for anyone juggling both FDA and EU MDR compliance.
Final Thoughts
In the end, this year’s FDA landscape feels a little like juggling flaming torches while riding a unicycle — possible, but not without singed eyebrows. Between workforce cuts, AI oversight, and a communication blackout, it’s easy to assume the agency’s losing its grip. But history tells us the FDA always bounces back, even if the rebound is messy. For medical device companies, that means opportunity: less competition for de novos, a clearer runway to get ahead on QMSR alignment, and a front-row seat to watch how automation reshapes review times. In short, it’s not time to panic — it’s time to stay alert, stay compliant, and maybe keep that cocktail shaker within reach.
Our top three suggestions for you?
Stay inspection-ready.
Double-check FDA databases yourself.
And maybe invest in a Magic 8 Ball — it’s about as reliable as predicting what the FDA will do next.
If you’ve made it this far, you’re already ahead of most teams.
If you want to keep going:
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The full video presentation: FDA Strategy 2025: Policy, Pressures and the Path to MedTech Clearance
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Blog: 10 Bulletproof Submission Tips for Medical Device Companies
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Online course: Understanding and Implementing QMSR
All optional—but they’ll give you a clearer picture of what “good” actually looks like in practice.
