Determining the intended use of a new medical device is an important step in the medical device development process. In this webinar, in2being Managing Director Gene Parunak breaks down the far-reaching implications of a device’s intended use.
In simple terms, the intended use of a medical device is what the device does, especially as it’s described in the product’s labeling. But the FDA’s definition—spelled out in the U.S. Code of Federal Regulations (CFR)—is broader.
The FDA defines intended use as “the objective intent of the persons legally responsible for the labeling of an article. . . . The intent may be shown by such persons’ expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives” (CFR Section 801.4).
The foregoing definition includes the first thing that comes to mind when intended use is mentioned—labeling claims. But it also includes other written descriptions of a medical device:
- User manuals
- Marketing materials
- Other written statements
In addition, the definition mentions other less obvious things the FDA considers in determining intended use:
- “The design or composition of the article”—the design and construction of your new medical device
- “The circumstances surrounding the distribution of the article”—the indications for use of your new medical device (i.e., the patient population it’s intended to treat, where and when it should be used, etc.)
- “Oral statements”—for example, the verbal statements of your company’s sales representatives
Viewed in this light, intended use is more than a regulatory issue; it lays a solid foundation for your medical device’s development process. It plays a central role in device classification, which, in turn, determines your pathway to regulatory clearance. It’s also a driving force in the design process.
As a full-service consultant for medical device development, in2being can help you holistically analyze your medical device’s intended use. Contact us today to learn more about how in2being can streamline your development process.
Video Transcript
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 labeling, 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, it’s 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.