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FREE On-demand webinar

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

Watch the 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?


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



Michael Drues, Ph.D.
Vascular Sciences



Jon Speer
Founder & VP of QA/RA
Greenlight Guru



About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.



ABOUT the presenter

Michael Drues, Ph.D., is a regulatory strategy consultant specializing in designing novel regulatory strategies to bring new and innovative medical products to market and in developing effective communication strategies between companies and regulatory agencies to minimize time to market and avoid delays.

His consultancy, Vascular Sciences is a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense. If you'd like to learn more click here.