FDA Regulations Experts Weigh in On Medical Device Trademark Dispute


FDA RegulationsThis case involves a trademark dispute between two manufacturers of consumer medical devices in Nevada. A company that offered a competing product with similar branding sued the defendant for trademark infringement, alleging that the defendant firm did not have any right to the trademark due to the fact that they were not compliant with FDA regulations. An expert was requested to determine the defendant firm’s adherence to FDA regulations, thereby establishing the validity of their trademark.

Question(s) For Expert Witness

  • 1. Are you familiar with FDA regulations regarding tobacco?
  • 2. Please explain why you are qualified to review this case.

Expert Witness Response E-009705

I have been providing FDA regulatory consulting to the medical device industry since 1978 with a total of 44 years of FDA regulatory experience. I worked at the FDA directly for 6 of those years. I have consulted with the condom industry on FDA compliance and I have a keen understanding of the relevant FDA regulations. Given my intimate understanding of this industry and my lack of conflicts, I think this would be something I could assist with.

Expert Witness Response E-010153

All consumer products are regulated by the FDA, including these devices. Given my experience as an FDA review chemist and my lengthy career in pharmaceutical R&D, quality control, and regulatory affairs, I am very comfortable helping to evaluate whether or not this company was compliant with the FDA. I have done some consulting for a major manufacturer of consumer medical devices regarding topical treatments and vitamin formulations.

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