As part of Covington’s ongoing Life Sciences Essentials webinar series, we will be presenting a program on Regulation of eHealth Products and Mobile Apps on February 25, 2015 (12:30-2:00 p.m. EST).
Our panelists, including two alumni of the FDA Office of Chief Counsel, will address:
- What factors determine whether an eHealth product is considered a medical device and subject to active FDA regulation?
- What avenues are there to obtain information from FDA about whether your eHealth Product will be actively regulated, and how can you affect/influence that determination?
- What role may eHealth play in personalized medicine and genetic screening, and what are FDA’s policies in this area?
- How might legislation impact the regulation of eHealth products?
- A comparison of FDA regulation of eHealth and mobile apps to regulation in the EU and China.
The program panelists are Scott Danzis, Cassie Scherer, John Balzano and Brian Kelly.
Click here to register. CLE credit will be available for CA and NY.