Impact of FDA Guidelines for Medical Devices and Biomaterials

Biopolymers are widely used to generate biomaterials that are used in medical devices. While the safety and effectiveness of medical devices are evaluated directly, the FDA does not regulate the approval of individual biomaterials.

Biomaterials are regulated indirectly as a part of a device. New material in a device should have supportive evidence that substantiates the appropriateness of that material in the device. For example, a new material used to create a heart valve should have evidence in terms of the acute and chronic toxicity of the implant, mechanical durability tests, blood interactions tests, and animal and clinical trial experience. However, a material receives certification in cases where the material by itself is a product, for instance a material product such as bone cement.