Vanderbilt’s Center for Technology Transfer and Commercialization will host a special seminar, “When Does a Medical Software/App Become a Medical Device?: Practical Considerations and FDA Guidance,” from 1:30 to 2:30 p.m. Tuesday, Nov. 19, at Jacobs Believed in Me Auditorium, 134 Featheringill Hall. Seth Mailhot, an attorney with Michael Best and Friedrich, LLP, will lead the discussion.
The 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.
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, he worked for the U.S. Food and Drug Administration from 1994 to 2006. He has worked on FDA-related matters for more than 20 years, starting in various technical and enforcement positions at the FDA. Mailhot counsels clients on all aspects of regulation by the FDA as well as related matters regulated by the USDA and Department of Health and Human Services.
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