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CTTC Seminar: FDA Guidance on Medical Software, Apps and Devices
Nov 14 2013
Tuesday, Nov. 19, CTTC will host a special seminar, "When Does a Medical Software/APP Become a Medical Device: Practical Considerations and FDA Guidance”. Leading the seminar will be Seth Mailhot, J.D., attorney at Michael Best and Friedrich, LLP.
This seminar will address the regulatory framework for medical software, specifically for the rapidly expanding field of mobile apps. With Vanderbilt’s significant involvement in software driven medicine and medical apps, this talk should be of interest to entrepreneurs, students, researchers, marketers and clinicians in this area.
Mailhot currently leads the FDA Regulatory practice at Michael Best and Friedrich, and is a member of the firm’s Transactional Practice Group in the Washington, D.C. office. Prior to entering private practice, Mailhot worked for the U.S. Food and Drug Administration from 1994 to 2006. Mailhot has worked on FDA-related matters for more than 20 years, starting in various technical and enforcement positions at the U.S. Food and Drug Administration. He counsels clients on all aspects of regulation by FDA, as well as related matters regulated by USDA and Department of Health and Human Services.