Choosing a Regulatory Submission Plan

We don't usually associate 'choice' with regulatory submissions. Usually we think of the requirement for a 510k or PMA as being cut and dried--the decision is already made, our job is to figure out what the decision is.

In this e Conference I've invited Janice Hogan (of Hogan an Hartson) to teach us how we, as manufacturers of medical devices, do have choices about our regulatory strategy. The type of submission we need depends on the claims we want to make for the device. The claims we want to make may be influenced by market forces as well as the device's physical performance.

For example, if I have a department full of people who know how to file a PMA, I'll be sure to word my claims so that a PMA is required and I can roadblock for my competitors. But if I'm a start-up firm and getting venture capital is my worry, I'll go after the easy claims first. My primary goal being to demonstrate that I can get a submission through FDA and generate income.

Work with the words...that is part of the message Janice will bring. If you are a regulatory professional in medical devices you should plan to attend this lively and informative e Conference.