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Impact of the Cures Act on the Medical Device Industry

MassMEDIC

Jan
18
2017

Date: January 18, 2017

Time: 12:00PM

Location: Webinar

 

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.

 

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Speakers

Professional Cropped Crane Tom Mintz

Thomas S. Crane

Panelist

Thomas S. Crane is a nationally recognized attorney who defends health care clients against anti-kickback, Stark Law, false claims, and whistleblower allegations. Tom’s work at Mintz includes litigation, internal investigations, and advising clients on corporate integrity agreements and disclosures.
Rodney L. Whitlock is Vice President of ML Strategies and a health care policy professional. Rodney has over 20 years of experience working with the US Congress as a health policy advisor. He also served as Acting Health Policy Director for Finance Committee Chairman Chuck Grassley.
Professional Hills Bethany Mintz

Bethany J. Hills

Panelist

Bethany J. Hills is recognized for her experience and insight on FDA matters. At Mintz, she advises health care providers on pre- and post-market issues. Bethany also helps international and US companies enter and navigate the US health care market.