When do we need FDA’s permission to market our device and when do we not?

Before you stop reading because you think this topic is a no-brainer, think again!

If your device fits the CFR definition of a medical device, it is regulated by FDA. If it does not fit the CFR definition of a medical device, it is not regulated by FDA.

Pretty straightforward… end of discussion, right? Maybe not.

A growing number of companies are getting warning letters from FDA for marketing devices without getting FDA’s “permission” first. Other companies are wasting a lot of time and money taking devices to FDA that do not need to!

Most importantly, some companies are missing huge opportunities to have a device regulated by FDA even though they may not be required!

In this workshop, we will explore the seemingly simple question, what is a regulated medical device? And how we can interpret the CFR definition of a device to our advantage?

Using the case study approach, these questions and others will be presented in an interactive fashion, including:

• What is and is not a regulated medical device?

• Does it matter if your device is a mechanical widget? Liquid? Software? Something else?

• Can a video game be regulated by FDA? What about a potato chip bag or chewing gum?

• What if your device never comes in contact with a patient?

• What if there are non-medical device functions within a regulated medical device (i.e., a so-called multiple function device)?

• If your device is not a regulated medical device, are there advantages of taking it to FDA anyway?

• Can a medical device be regulated by FDA and not regulated by FDA at the same time?

• Q&A session

This is just the tip of the iceberg!

Bottom line: there are multiple interpretations of the CFR definition of a medical device and there are advantages and disadvantages to each interpretation.

So unless you understand all of the possibilities — not just the common ones – and the advantages and disadvantages to each – how can you decide which is best for you?

Who should attend?

• Medical Device Executives

• Regulatory Affairs Professionals and Management

• Quality Professionals and Management

• Clinical Affairs Professionals and Management

• R&D Engineers and Management