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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.
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.
Using the case study approach, you will 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?
Learn more here: https://www.greenlight.guru/webinar/general-wellness-devices