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

M.Drues webinar - 11-24-20
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
Register Now  

Hosted by

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Presenter: Mike Drues

President, Vascular Sciences

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru


About Vascular Sciences
Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996. These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH). Visit their website tolearn more.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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