Identify the innovation’s intended use and determine if your idea/solution meets the definition of a medical device.

The intended use determines the regulatory oversight, including testing data, regulatory approval pathway, and classification necessary to gain FDA approval. This is important to understand the costs and time-frames involved. While some products are obviously medical devices, others are not. For example, solutions used by consumers for general wellness are not.

It is important to understand and define the medical condition or problem the solution intends to address, the intended patient population, the intended purpose of the solution, any limitations or contraindications (including specific patient populations or adverse conditions), and any other factors that may impact the intended use. Follow regulatory guidance to answer questions regarding the definition of a medical device.