Impact of the Cures Act on the Medical Device Industry

The 21st Century Cures Act is a significant bipartisan piece of legislation that was signed into law on December 13, 2016 that will significantly affect the med tech community. MassMEDIC is hosting a webinar on January 18, 2017 in collaboration with the Health Section of Mintz Levin and its consulting affiliate, ML Strategies. The webinar will start with the political path taken to accomplish the nearly 1,000 pages of the new law, the compromises made and the key implementation issues facing the new Trump Administration. Then, we will take a deep dive into the provisions impacting med tech - such as the creation of a breakthrough device pathway, emphasis on a review of FDA's use of the least burdensome review requirements, a new definition of "medical device" that specifically carves out five categories of medical software and many other provisions aimed at improving access to patients and clarifying review processes and device classifications. Attendees will come away understanding the benefits and challenges this monumental legislation presents for product development and implementation issues ahead.