Video: A Drop of Intended Use
This is the first in an ongoing series of “droplet” videos intended to communicate key concepts in the medical device development process. Our hope is that these videos will create a higher level of dialogue and inherent understanding in our local, regional, and national innovation ecosystem.
“Today we’re going to talk about your medical device’s intended use.
In the most basic terms, your intended use is what you’re saying that your device does. Intended use stands or falls largely on your product labelling, which as we know, encompasses more than just the “label” on your product, and includes user manuals, marketing materials, sales representative statements and more.
Here’s how the FDA defines intended use:
“...the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article.”
In short, its what you communicate to others that the device is good for.
Don’t let anyone tell you that your intended use is “just” a regulatory issue. Your intended use is central to the device classification process, but it also drives the technical design input process, and really sets a foundation for your development pathway. If you say your amazing new scalpel is going to cure cancer, then your whole dev team had better be prepared to demonstrate through objective evidence, including clinical trials and more that your device does indeed cure cancer. If on the other hand you say that your amazing new scalpel just does a great job at cutting tissue, then you’ve got a nice and “easy” class I device with a minimally burdened development path ahead of you.
For more on how intended use affects your development process, see our other videos, or reach out and chat with our team.
Contact us to learn how in2being can be your medical device development partner.”
Not Legal Advice.
FDA Definition of Intended Use: