Understanding the FDA Medical Device Premarket Regulatory Process Helps Streamline the Path to Commercialization

Abstract

The FDA regulates all products that meet the definition of a medical device defined in Section 201(h) of the U.S. Federal FD&C Act. Entrepreneurial medical device firms face many translational challenges, including regulatory issues. Device classification determines the appropriate type of premarketing application and the regulatory requirements for new medical devices. Understanding the risk-based regulatory paradigm in premarket evaluation, FDA's device classification system, and conforming level of control should improve the outlook of commercial success in the introduction of novel devices in the U.S. market.