“My career on both sides of the medical device industry means that I can help you navigate regulatory issues.”
Thomas C. Knott
Senior Regulatory Advisor
- Washington, DC
- tknott@ofwlaw.com
- 202-518-6331
Tom draws from his 34-year career at FDA, including time as a district laboratory analyst and compliance officer, a compliance officer in ORA headquarters, and branch chief in the Office of Compliance in CDRH. Since then, he has consulted on medical device issues. He has guided clients through the FDA regulations to be able to market their medical devices.
Practice Areas
- APHIS Animal Health
- Customs & Import/Export Regulations
- Due Diligence
- Enforcement & Litigation
- Facility Registrations
- FDA Food Law and Food Safety
- Food Labeling & Advertisement
- Food Recalls
- Food Service, Restaurants & Retailers
- Inspections
- Meat, Poultry & Egg Products
- National Organic Program
- Packers & Stockyards Act
- Trade Associations
Past Experience
- CHEMIST AND IN VITRO DIAGNOSTIC DEVICE SPECIALIST, FDA Baltimore District Office
- CONSUMER SAFETY OFFICER (COMPLIANCE OFFICER), Baltimore District Office of the Food and Drug Administration.
- CONSUMER SAFETY OFFICER (COMPLIANCE OFFICER)
- SUPERVISORY CONSUMER SAFETY OFFICER
- SENIOR REGULATORY CONSULTANT AND FDA EXPERT
- SENIOR REGULATORY ADVISOR, FDAImports.com,
Credentials
Education
Johns Hopkins University
B. A. in Chemistry
1971
Phi Lambda Upsilon
University of Maryland at Baltimore
Coursework for M. A. in Clinical Chemistry 1984-1985
Attended under FDA’s Long-Term Training program, which was not designed to obtain a degree
News & Insights
May 21st, 2018
January 24th, 2018
September 19th, 2017
