Guide to US FDA Requirements for Novel and Innovative Medical Devices

Advances in technology continue to change the landscape of the medical field.  The range of novel and innovative medical devices and combination products continues to expand rapidly, driven by new techologies such as artificial intelligence and machine learning (AI/ML), 3D printing and additive manufacturing, virtual and augmented reality as well as nanomaterials. 

The challenge for both industry and the US Food and Drug Administration (FDA) is to determine within the existing regulatory framework the best way to bring these new products to healthcare providers and patients as soon as possible while also supporting safety and effectiveness. 

This white paper examines and explains current regulations and requirements that manufacturers of novel and innovative medical devices must meet in order to market their products in the US.