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FREE ON-DEMAND WEBINAR
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?
Watch the webinar
Using the case study approach, we’ll address these questions and more in an interactive fashion:
- 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
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