Seth Mailhot Photo

Seth A. Mailhot

Practice Group Leader, FDA Regulatory


Seth brings more than 20 years of experience in a full spectrum of U.S. Food and Drug Administration-related matters to his leadership of the firm’s FDA Regulatory practice group. Incorporating his training as a chemical engineer and experience gained while serving the FDA with a practical business approach, Seth offers clients a valuable perspective on highly technical areas of the FDA’s regulatory authority.

Prior to joining the firm, Seth worked for the U.S. Food and Drug Administration in various capacities and in key roles at several AmLaw 100 law firms.

Seth brings significant value to clients in all aspects of FDA law and regulation, including:

  • Counseling clients on significant FDA enforcement matters before the Department of Justice
  • Advising on Design Control requirements for medical device software
  • Developing procedures and risk assessments consistent with Food Safety Modernization Act requirements
  • Drafting and negotiating corporate agreements involving FDA-regulated products and services
  • Assisting Intellectual Property litigation teams on matters involving FDA-regulated products

In addition to counseling clients on all areas of the FDA, Seth advises on other regulatory matters relating to:

  • United States Department of Agriculture (USDA)
  • Environmental Protection Agency (EPA)
  • Department of Health and Human Services
  • National Organic Program
  • Federal Insecticide Fungicide and Rodenticide Act (FIFRA)
  • Health Insurance Portability and Accountability Act (HIPAA)
  • Health Information Technology for Economic Clinical Health Act (HITECH)


Food and Agriculture

Seth counsels on matters related to human food, feed and dietary supplements, including providing advice tailored to the dairy industry and ethanol producers. Seth leads Michael Best’s food safety panel, which assists clients with generally recognized as safe (GRAS) self-certification, among other reviews. The FDA Regulatory group provides guidance on everything from food labeling and advertising to petitions for direct and indirect food additives.

Medical Devices

Seth handles a range of pre- and post-market regulatory issues involving medical devices, from crafting regulatory strategies for device development to the regulation of both commercial and medical electronic products. Work includes the preparation and prosecution of premarket notifications [510(k)s] and premarket approvals (PMAs) and development of quality systems compliant with FDA’s Quality System Regulation [21 C.F.R. part 820].

Mobile Medical Apps and Other Medical Software

Medical software presents unique regulatory challenges requiring compliance with highly technical requirements. Seth has successfully obtained marketing authorization for numerous telemedicine and other medical software applications. In particular, Seth has helped clients with preparing the detailed submissions disclosing important aspects of the software design control process.

Drugs and Biologics

Seth has counseled brand and generic manufacturers and secondary manufacturers on a full scope of Hatch-Waxman matters, including exclusivity periods for brand and generic drugs and the citizens petition process. Seth also helps with other technical requirements, including drug registration and listing, compliance with current good manufacturing practice (cGMP) requirements, and preparing detailed responses during premarket reviews of new drug applications (NDAs) and abbreviated new drug applications (ANDAs). 


Seth has long counseled clients in the tobacco industry on compliance with the Family Smoking Prevention and Tobacco Control Act, and currently advises manufacturers, retailers and distributors on product approval, marketing and sales practices. His counseling includes advice to cigar and electronic cigarette manufacturers on FDA regulations and strategies for bringing those tobacco products through the premarket application process, preparing premarket tobacco product applications (PMTAs) and substantial equivalence reports (SE Reports), among other submissions.

Professional Activities

  • Lecturer, Catholic University of America, Columbus School of Law, 2012-Present



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