FREE ON-DEMAND WEBINAR
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?
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?