FDA Regulations Experts Weigh in On Medical Device Trademark Dispute

Case Overview

This 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.

Questions to the FDA Regulations expert and their responses

Are you familiar with FDA regulations regarding tobacco?

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 have consulted with the condom industry on FDA compliance and I have a keen understanding of the relevant FDA regulations.

Please explain why you are qualified to review this case.

Given my intimate understanding of this industry and my lack of conflicts, I think this would be something I could assist with.

About the expert

This expert is recognized nationally for his extensive knowledge of US FDA regulations and quality system implementation. He is a former US FDA supervisor of field operations, and has been consulting to the FDA regulated industries of medical devices, pharmaceuticals, foods and cosmetics for over 42 years. This expert has been invited to speak on FDA policy on both a national and international scale. He is an Internationally Certified Lead Assessor for ISO13485 and is on the editorial advisory board of the Institute of Validation Technology. He is published in the Journal of CGMP Compliance on both preparing and responding to FDA 483s and warning letters, and currently works as a consultant to numerous companies on FDA regulations.