Whether you are developing a new medical device or a second generation of an existing device, what are the FDA & HHS requirements that you need to follow? There’s a lot to take into account– design controls, nonclinical testing, potential clinical trials, marketing submissions, labeling, marketing and advertising, and postmarket surveillance. We’ll discuss the framework for FDA’s regulations to help guide your development. In addition, we’ll cover recent developments in how the government regulates Medicare coverage for innovative emerging medical technology, the need to be thoughtful early on about evidence development when contemplating your approach to market access, and additional HHS anti-fraud and compliance watch-outs when negotiating customer contracts.
|Stephanie Philbin (FDA Regulatory Strategy)|
|Matt Wetzel (HHS Regulatory & Commercial Strategy)|