With an education in chemical engineering and a prior career at the U.S. Food and Drug Administration, Seth A. Mailhot brings clients rare regulatory insight on food, medical device and drug matters.
As Leader of the firm’s FDA group, Seth handles a broad array of matters involving FDA-regulated products and services including food, medical devices, pharmaceuticals, biotechnology, tobacco, radiation-emitting electronic products and cosmetics.
He assists clients in premarket strategies, advises on postmarket compliance, handles enforcement matters – including those before the U.S. Department of Justice – and drafts and negotiates corporate transactions.
Seth began his career as a chemical engineer for more than a decade at the FDA, conducting regulatory research, performing inspections of regulated industry and serving as a compliance officer, followed by nearly 15 years in private practice. Clients appreciate his multidisciplinary experience when faced with highly technical regulatory issues.
- Regularly advise clients on compliance and litigation involving Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), which requires labeling of products containing “chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.”
- Routinely defend clients in claims under California’s consumer protection and competition laws: Consumer Legal Remedies Act (CLRA), False Advertising Law (FAL) and Unfair Competition Law (UCL).
- Advise clients on low acid canned food (LACF) process registration.
- Assist with software design controls of medical software and health IT products (including mobile medical devices).
- Prepare and prosecute premarket submissions for medical devices [510(k) and PMA] and drugs (NDA and ANDA).
- Assist clients with digital health software matters, including requirements for design controls, mobile medical apps, exemptions for medical software, and compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act.
- Worked on research projects and sample testing for medical devices and radiation-emitting electronic products (e.g., microwave ovens and lasers).
- Manage patent term extension applications for products approved by the FDA, and state registration and licensing of drug distributors and manufacturers.
- J.D., New England School of Law
- B.S., University of Massachusetts
- U.S. Patent and Trademark Office
- District of Columbia
Professional Associations and Memberships : Food and Drug Law Institute (FDLI)
Rate : $$$