One good exercise for this module is to try to discuss and figure out the regulatory pathway for a medical device. So let’s give it a whirl!

I am not a regulatory person. All I have is experience, and I can be wrong on my guesses just as you can. So what, though? The point is to discuss how we think the FDA would handle something. Regulatory people do the same thing in real life. They just have more information and more immediate experience to draw from.

So let’s get started.

What kind of regulatory pathway would be required for an antibiotic-releasing hip stem?

Is it a device, drug, biologic, or combination?

What is its “primary mode of action?

Is it Class I, II, II?

What claims would you recommend we make for it? An example of a claim is “fights infection in bone (osteomyelitis) and reduces incidence of hip implant failure”. Any claim that you say, you have to lay out a plan to prove it.

Drawing on some of your experience from the week we did pre-clinical research, what pre-clinical research studies would you recommend be done to prove the claims?

Guessing as best you can, what sorts of clinical trials would you recommend in the IDE? Does it need an IDE at all?

This is very similar to the discussion you will have about the device in your final project, so practice now!