Wednesday, September 01, 2010
By Mya Thomae
Category: FDA General
So, let's be honest: yesterday's webinar on the proposed 510k changes was a disappointment. I suppose that's inevitable when you lift your agenda from a radio call-in show. Caller three... you're on the air!
In case you missed it, here's what I remember from the meeting. I was a bit distracted, so I might be getting a few of the details wrong.
QUESTION: The 510k process is really confusing. Has FDA ever considered improving their communications?
ANSWER: Yeah, that's a great idea. Maybe we should schedule a public webinar or something.
QUESTION: I'm confused. This is a webinar, but there are no visuals? Why didn't I just call in on the phone?
ANSWER: Oh, we had cameras set up and everything. But then Dr. Shuren thought it was Hawaiian shirt day, so we had to turn them off.
QUESTION: I have a three-part question. First, what will the new requirements for clinical data be for my product? Second, can I get you to put that in writing and never change it? Third, shouldn't everything you do be subjected to proposed rulemaking?
ANSWER: It's unfortunate you made that a three-part question. When you started, we actually had a pretty clear process for regulating your product, but by the time you finished, we had already published five new Notices to Industry. Sucks to be you, I guess.
QUESTION: Have you considered that you're a drag on industry?
ANSWER: Have you considered that these questions aren't anonymous?
QUESTION: OK, seriously... why can't you have one set of consistent rules?
ANSWER: FDA regulates everything from hot dogs to MRIs. Do you honestly think that all those things should be regulated the exact same way?
QUESTION: What's the difference between "clinical utility" and "clinical usability"?
ANSWER: Amazingly, we think that these words should refer to different things. We're also working on finding a word that falls somewhere between "clearance" and "approval" for the new Class IIb products. We're thinking of calling that an "affirmation".
QUESTION: That's it, I can't take any more.
ANSWER: Welcome to our world.
Tags:
510(k),
CDRH,
FDA,
Industry,
IVD,
PMA
