This post was mentioned on Twitter by ASSURX: Is the FDA getting ready to crack down on medical device clinical trials? (AssurX blog) http://bit.ly/4Gcz0i #fda #medicaldevices #assurx…

But yes, if there’s the possibility of getting some discussion and pushback, I’m all for it. Today, all day, is work to pushback at FDA about their request for “clinical safety and efficiency” for a 510(k) product – they want human proof of the benefit of a device – this is way outside their charter and the scope of the regulations, but if we don’t finesse it, we’ll end up having to PMA. As my daughter says, “Happy Day? Not!”

Michael

I’ve personally done too much work on various standards and harmonization committees over the years, so I have spent a lot of time in small rooms with all the players, and I think that we (by which I mean all the startups and entrepreneurs) are just going to have to suck it up and adapt. The notion of “Least Burdensome” was so abused that those of us who are trying to do honest work are still getting tarred by the same brush.

The FDA has to follow the instructions of Congress, but also tacks with the winds of politics in their interpretations. It’s easier to lean on the small players, and the big names have the money and market access already, so this is just going to be another one of those trends that we have to adapt to. I’ve not seen any evidence that the FDA is reaching out to innovators, and aside from AAMI (which is non-political) there aren’t any neutral players anymore.

We’re stuck with the goofy predicate device method for intermediate risk products in the USA, and there’s no real solution. We had a decade or so of relatively free ride, now the pendulum has swung back. The shame is that the real innovators are the ones least able to deal with the added burdens that are being piled on. So while I am optimistic about the long term, right now I just don’t see how we are going to be able to bring really useful innovations to the market in the USA.

Personally, I can say that we are getting zero traction when we tell the FDA that we are small and don’t have the ability to go out and spend another million dollars and wait another six or nine months – the investors are all sitting on their hands in this economy. There’s no flexibility at the agency, and no way to fund Yet Another Set of Animal Trials . So the EU and Asian economies will be getting the benefit of American innovation, and the investors there will collect the returns while their health care systems get the technology. Meanwhile, here in the USA, innovators and entrepreneurs in medtech are asking themselves this: “Why am I having to work so hard?”

Long answer to a short question, sir. But it’s been a brutal week, arguing about clinical risks with the agency, and so this is near to my heart and mind.