Why can’t I just use medical grade materials for my product?
It’s easy to think your device will be safe because you’ve only selected “medical grade” materials. However, when determining if a device is safe, the FDA analyzes the entire finished device, not the components. If you select “medical grade” components, you’ll still need to ensure your device is safe after it’s been assembled, packaged, and sterilized (if applicable). Additionally, “medical grade” is not a term that is recognized by the FDA. While there are standards for raw materials (like USP Class VI), using materials that meet these standards doesn’t exempt you from further testing.
To ensure that devices that contact patients are safe, the FDA requires biocompatibility testing. This is true even if you think all of your components are “medical grade.” While the material composition is one factor in whether or not your device is biocompatible, you also have to consider geometry and processing. The only way to avoid biocompatibility testing is if you use a part where the material, geometry, and processing are completely unchanged from an already-cleared device. If you change the part geometry (for example, increasing surface area) or change how the part is processed (for example, changing to die-cut instead of laser-cut), you need to show that your final, processed device is still biocompatible.
The level of biocompatibility testing you need depends on both the type of contact your devices makes with patients as well as the duration of that contact. For example, devices that only contact skin require less testing than devices that are implanted. Devices that are intended to be in contact with the skin continuously (like a wearable device) require more testing than those that make brief contact (like a thermometer). Not sure what type of testing your device will need? Check out Nemedio’s calculator!