Peter Barton Hutt: 510(k) Flawed, But the Rules are Simple

Although Hutt spoke late in the conference, his succinct and pragmatic advice caught my attention. Amid a long conversation about the future of FDA, 510(k)s, and what should be done about both, Hutt had only two pieces of advice. " Step one," he said, "find out what FDA wants. Step two—do it. It doesn't matter if what they ask for is stupid or brilliant. It doesn't matter if the request is reasonable. If you don't give FDA what they ask for, you aren't going to get your device approved."

With that, Hutt brought the conversation down to a basic "because I said so" level. And I can already hear the objections (I went through a few of them of my own the moment he spoke). I don't like the presumption of an infallible FDA (because its not); nor am I comfortable with blindly following rules that don't make sense (or in the case of medical devices, trying to guess the rules based on what has come before).

Despite my angsty leanings, however, I can't help but see the truth of Hutt's statement.

By the way, there is a lot more contained in the InHealth conference than Hutt's telling like it is. InHealth conducted a smart sruvey on how industry feel about 510(k)s and presented their findings. Furthermore, a panel of experts included Jeffrey Shuren, Susan Alpert (Medtronic's former senior vice president and chief regulatory officer), and Philip Phillips, and Hutt.

We'll have much more coverage of this event in the next few days. I just wanted to get my favorite part of it here.

—Heather Thompson