Business Ethics Expert Discusses Alleged Sale of Defective Medical Devices

Case Overview

Questions to the FDA Regulations expert and their responses

Please describe your background in business ethics.

I have extensive experience reviewing medical device and drug manufacturers for both FDA compliance and proper safety recording. In addition to serving as an independent reviewer, I currently develop and teach independent classes in a variety of FDA compliance topics.

What experience do you have with ensuring the ethical selling of medical devices?

I can speak to not only the company's lack of compliance when launching a new device, but also how a company should respond to safety issues that arise with the device's use. The questions of focus here are: what did they know, and when did they know it, what the company should have known, and when they should have known it, and what the company should have done and when they should have done it. My first step would be to look at the initial 510(k) submission for this device and examine how truthful they were in their submission. The FDA has the assumption of complete information when the 510(k) is filed by the company, thus the company is responsible for ensuring their submission is truthful and accurate. A 510(k) for a medical device is different from a drug and must prove that the device is substantially equivalent to the predicate device. It is also possible that after the initial 510(k) submission, the company changed the design in a way that impacted the ability to sterilize it. I would be able to examine if they took the appropriate steps necessary when making such a change, should it be completing an additional 510(k) submission or informing the FDA in some way. In a case like this, the chronology of events is absolutely key. I am familiar with a hospital's duty to report serious adverse events, such as superbug outbreaks, to the FDA. I would be able to review the hospital's action in regards to informing the FDA of a superbug outbreak, or anything else that they knew of and had a duty to inform of.

About the expert

This expert has over 30 years of experience in drug, biologic, and medical device development. He earned his BS in zoology from the University of Iowa, his MS in physiology from the University of Maryland, and his PhD in physiology from the University of Georgia. He began his career as a drug reviewer for the Food and Drug Administration (FDA) and later became an instructor at the SAS Institute. His work has included experience in regulatory affairs, protocol development, design and execution of studies, data collection, data management, data reporting, statistical analysis, software programming and validation, technical writing, and FDA compliance. Currently, he serves as the principal consultant at an FDA compliance firm in Washington D.C., where he leverages his prior experience as an FDA drug reviewer to prepare FDA submissions (IND, NDA, BLA, IDE, 510(k), PMA) and conduct independent GCP audits.

E-023161

Specialties:

FDA Regulations