FDA Pre-Submissions with Larry Stevens

What happens when you put three regulatory consultants with over thirty years of combined FDA experience in front of an audience - and then hand them a microphone?

Larry Stevens, Rob Packard and I got together and had some fun doing a little FDA role-play, talking about the do's and don'ts of the process, where accessory devices fit in, and what we've seen in our own personal experiences with the FDA.

Hint: Larry used to work for the FDA, so this is well worth watching.



Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501 k,
medical device regulation, FDA 510(k), FDA 510k clearance, regulatory affairs,
FDA 510k approvals, regulatory affairs medical devices, FDA pre submission, regulatory compliance, FDA submission, FDA 510k submission guidance