Navigating the complex landscape of the US Food and Drug Administration (FDA) pre-market submissions can be a daunting task for medical device manufacturers. Understanding the different types of submissions, their specific requirements, and the submission process is crucial for a successful market entry.

Multiple function device products are medical products that have at least one device function (medical) and one non-device function (non-medical) or other function. Among these, some are subjected to FDA’s Regulatory oversight as medical devices, while others are not. Hence, FDA issued a final guidance addressing the review of medical products that contain both, the medical and the non-medical functions.