Medical Devices 2011 - Clear as Mud: Obtaining and Marketing Your 510(k) With Today's FDA

Description
How do you obtain a 510(k) in today's environment at FDA? And once you get it, how can you market a product with a general intended use statement when your product can be used in many patient populations?

What to do when your things do not go right, how to answer Additional Information (AI) letters, when and how to push back, meeting with FDA and who to take and how to prepare, the appellate process at CDRH, what avenues to pursue and when.

When you get your 510(k) how to market your 510(k) , what communication strategy to adopt, what to do when FDA disagrees with your promotional positioning.

Proper understanding of 510(k) process from start to finish is mandatory to avoid problems along with understanding of promotional strategy is very much essential for all companies for success in this complex world of regulations.