The Evolving Door of Medical Device Rules and Regulations

The Evolving Door of Medical Device Rules and Regulations

Wednesday, Nov. 14, 2012 | 1:30 p.m. – 4:30 p.m. ET
Register Now!

*Note: 2.25 hours of CLE Pending

The laws and regulations faced by the medical device industry today are ever evolving.  In this seminar, Barnes & Thornburg attorneys will provide insight on how the legal climate for the medical device industry has changed in 2012, how the presidential election may impact you, your business and your industry, and what steps you can take to ensure your company is in compliance and prepared for the future.


What the FDA Did This Summer
Lynn Tyler, the Chair of Barnes & Thornburg’s Food, Drug & Device Practice Group, will discuss changes to medical device regulation included in the FDA Safety and Innovation Act and the FDA’s implementation of them. He will also discuss several important changes made by a final rule published in August 2012 and effective October 1.

Post-Election Analysis
Craig Burkhardt, a partner in the firm’s Federal Relations Group, will provide insights into how the results of the November election may impact the healthcare industry and what the potential ramifications for your business may be.

Litigation Avoidance and Preparedness in the Age of Social Media and E-Discovery
Guna Rogers, an attorney in the firm’s Drug & Medical Device Litigation and E-Discovery practice groups, will discuss the fundamentals of an effective document retention policy – and why you need to understand where your company’s data resides. She will also discuss why it’s vital to have a social media use policy, and the key considerations to avoid litigation in light of a recent NLRB ruling and risks of improperly advertising medical products.

New Capital Raising Strategies for Medical Device Companies

This spring, President Obama signed into law the “Jumpstart Our Business Act” (the JOBS Act), which has the potential to radically change the way biomedical companies raise capital for product development and expansion. When the SEC completes its rule writing, companies like yours will have the opportunity to solicit publicly for private investments, something which has been strictly prohibited. In addition, the new legislation provides new opportunities for raising funds through “Crowdfunding,” which many believe will expand the pool from which technology may raise early stage capital. Marcus Chandler, Co-Chair of the firm’s BT VentureTech Practice Group, will discuss how this applies to the medical device industry and how you can best be prepared.

About Barnes & Thornburg LLP
With more than 600 attorneys and other legal professionals, Barnes & Thornburg is one of the largest law firms in the country. The firm serves clients worldwide from its offices in Atlanta, Delaware, Chicago, Indiana, Los Angeles, Michigan, Minneapolis, Ohio and Washington, D.C. For more information, please visit us online at

Date and Time:
Wed., Nov. 14, 2012
1:30 p.m. – 2 p.m. –  Registration
2 p.m. – 4:30 p.m. – Program

Program followed by cocktail reception

Barnes & Thornburg LLP
Fifth Floor Conf. Center
11 South Meridian Street
Indianapolis, IN


Cost: Complimentary

Visit us online at


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