Comments on: The FDA wants to regulate your connected toothbrush

By: geoffclapp

geoffclapp — Tue, 03 Jul 2012 17:20:02 +0000

This is not really a problem of mHealth, per se – remember even a tongue depressor is a Class I 510(k) device. http://www.accessdata.fda.gov/cdrh_docs/pdf/k992995.pdf

Could the process be improved? Certainly, unquestionably – but the idea that the FDA is holding back innovation is a little overstated. Getting a 510(k) is just not that hard.

I’ve talked to Alex a few times, and I am sure he will be a great entrepreneur, either with this or something else, but the FDA is not going to make or break his business.

I am no FDA apologist – after more than 7 510(k)’s and many on-site audits (including a 510(k) where no good predicate existed), I have lots of beefs with the FDA.

At the same time, I’m not sure our market is served well by a total lack of regulation, either – the downside is AppStores full of ineffective, unsafe products (if it’s not already that way) that turn people away from mHealth.

There’s a balence, and that’s what we should be striving for.

By: digideth

digideth — Sat, 30 Jun 2012 05:29:18 +0000

another government agency stifling innovation because they haven’t figured out a way to make $ from it.

By: brown_te

brown_te — Fri, 29 Jun 2012 19:23:26 +0000

Dear FDA – perhaps when you’ve done something to: prevent multiple E.Coli outbreaks/year, fast-track approvals on life/death oncology drugs, address the growing problem of shortages on approved drugs, and perhaps encourage some innovation on devices like insulin pumps/meters – then you could worry about……toothbrushes.

By: antonwahlman

antonwahlman — Fri, 29 Jun 2012 18:44:30 +0000

A government large enough to….