SETH MAILHOT leads the FDA Regulatory practice at Michael Best & Friedrich LLP, and is a member of the firm’s Transactional Practice Group in the Washington, D.C. office. Mr. Mailhot has worked on FDA-related matters for over 20 years, starting in various technical and enforcement positions at the U.S. Food and Drug Administration. Since entering private practice, Mr. Mailhot counsels clients on all aspects of regulation by FDA, as well as related matters regulated by USDA and Department of Health and Human Services (such as the requirements of the National Organic Program, and compliance with the Health Insurance Portability and Accountability Act of 1996, or HIPAA, and the Health Information Technology for Economic and Clinical Health Act, or HITECH). Advice spans issues impacting regulated product manufacturers, investors, distributors, retailers, and users (such as device user facilities with an obligation to report adverse events to FDA). Mr. Mailhot’s background in Chemical Engineering and practical experience at FDA provides a unique perspective on the highly technical areas of FDA’s regulatory authority, such as the Design Control requirements for medical device software. He combines his technical knowledge with a practical business approach, and counseling includes drafting and negotiating various types of corporate agreements involving FDA regulated products and services. He is also a licensed Patent Attorney, and has assisted several IP litigation teams on litigation matters involving FDA regulated products. Mr. Mailhot’s experience with FDA included time working with the U.S. Attorney’s Office in Boston, and he applies this experience to counseling clients on significant enforcement matters.