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