Devices & Diagnostics, Policy

Don’t worry medical device people! Franken and Klobuchar will save us!

If you're banking your hopes on Minnesota's senators, think again. Perhaps Franken and Klobuchar can mitigate some of toughened regulations but there's only so much that they can do.

For months, Minnesota’s medical device community has fretted the Food and Drug Administration will toughen its 510(k) program to the point where innovation will wither on the proverbial vine.

But alas, good news! From the office of Sen. Al Franken Friday:

Franken Meets with FDA Head, Secures Commitment to Improve Medical Device Approval Process

Sen. Franken, in a conference call with more than 50 Minnesota medical device executives on Friday, said that FDA Commissioner Margaret Hamburg is taking seriously the concerns regarding the 510(k) program, which governs approval of certain new medical devices. Commissioner Hamburg committed to releasing the specific plans for changes to the regulatory process by the end of the year. While the FDA is currently gathering public input on its plan to modify the 510(k) program, the Commissioner committed to Sen. Franken that additional public comment will be sought before changes are made.

I guess we can stop worrying now.

Is it my imagination or does Franken’s news seems kind of underwhelming? What Franken actually accomplished is tough to say except that it doesn’t really seem to mesh with the bolded headline.

I’m not trying to knock Franken. Instead, I want to give the medical device community, which is hoping Franken and Sen. Amy Klobuchar will somehow ride to the rescue on a white horse, a hard dose of reality:

Change is coming to the FDA and the 510(k) and the medical device community won’t like it.

It’s really not a matter of if but rather when. If you’re banking your hopes on Minnesota’s senators, think again. Perhaps Franken and Klobuchar can mitigate some of  toughened regulations but there’s only so much that they can do.

So if you’re in denial, better snap out of it. Change is coming and you’re not going to like it.


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