General Wellness Devices & Wearables: Regulatory Options You Need To Know

Most medical device companies take their products to FDA prior to marketing. But is there a way to legally market a medical device without taking it to FDA first?

Maybe! The “general wellness exemption” provides a way to legally market certain medical devices without FDA clearance or approval.

Is this a new idea? Absolutely not! Companies having been doing this for decades; however, some companies have gotten in trouble for doing so improperly.

To help, FDA issued the General Wellness: Policy for Low Risk Devices guidance here. Despite this guidance, many companies still struggle with understanding which devices qualify under the wellness exemption and what documentation is necessary to support such a claim.

In addition, many companies don’t realize that the same device may be marketed as both a wellness device and as a 510k, de novo or even PMA at the same time. In fact, the wellness exemption offers an opportunity for label expansions to FDA regulated devices in the future.

When used effectively, the general wellness exemption offers significant advantages in to market sooner. But if not used properly, the wellness exemption can significantly increase the regulatory risk of punitive action.

Watch the webinar

Using the case study approach, participant will specifically learn:
      • What is the general wellness exemption and how can we use it to get to market faster?
      • What are the regulatory challenges of wearable medical devices?
      • What can I say in my label under the general wellness exemption?
      • What does risk mean in the context of a wellness device?
      • Why is usability for wellness devices more important than traditional medical devices?
      • How can I use a wellness device as a label expansion later?
      • Do other countries recognize wellness devices?

In this presentation, participants will learn best practices to avoid timely and costly mistakes and creative ways to use the general wellness exemption to their advantage!

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

Hosted by

M.Drues Headshot circle (3)
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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