FDA's MDDS Guidance: Industry Impact | mHealth Open Mic Series


Mar 27, 2015 1:00pm - 2:00pm EDT
Virtual Event

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 Open Mic Web Series

Does FDA’s MDDS Final Guidance Have a Profound Impact on the Medical Device Industry?

1. What is FDA guidance?

2. What is in the final MDDS guidance of 2015? (what it is, what it does, how it impacts medical technology companies)

3. What updates are found in the 2015 update to the FDA Mobile Medical App Final Guidance?

4. What to consider in commenting on the  draft FDA General Wellness: Policy for Low Risk Devices and the draft FDA Medical Device Accessory Guidance.

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 Guest Speaker

 Zach Rothstein

Zach Rothstein

Deputy Senior Counsel, Public Policy at Samsung Electronics

Zach Rothstein is Deputy Senior Counsel, Public Policy at Samsung Electronics where he is responsible for U.S. medical device and healthcare regulatory and policy issues that affect the company’s various businesses.  Prior to joining Samsung, Zach was an Associate Attorney in the FDA and Healthcare practice at the law firm of Morgan, Lewis & Bockius LLP.  Zach received his J.D. from The Catholic University of America, and his B.A. in political science and criminal justice from Indiana University.



Event Contact Information

David Collins
Sr. Director Healthcare Information Systems
FDA, MDDS, MMA, mobile, Apps