Understanding the FDA Medical Device Premarket Regulatory Process Helps Streamline the Path to Commercialization
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.
Carole Carey is an IEEE senior member and a member of the IEEE Eta Kappa Nu Honor Society. She currently serves as chair of the EMBS Standards Committee, liaison to the IEEE Standards Association, and was recently selected as a recipient of the 2016 IEEE-SA Standards Medallion Award. She is a former U.S. FDA official in the Center for Devices and Radiological Health (CDRH) with over 23 years of regulatory science experience as a Scientific Reviewer and International Advisor. As a Reviewer, she was team leader of highly complex, innovative cardiovascular devices and a peer-reviewed expert regulatory review scientist. In this capacity, she was also active in the development of industry consensus standards in her areas of specialization, both at the national and international levels. As a Mansfield Fellow, she trained side-by-side and collaborated with regulatory counterparts in Japan’s Ministry of Health, Labour and Welfare (MHLW) and its scientific review arm, the Pharmaceutical and Medical Devices Agency (PMDA) — on regulatory device issues, scientific matters concerning device safety and effectiveness, the recognition of international standards and global harmonization initiatives. Later, she served as Director of International Staff in FDA CDRH. Furthermore, she conducted device regulatory workshops in Europe, Asia and Latin America. Currently, she is a regulatory consultant providing advice and strategic approaches in premarket submissions, investigational device clinical trials and postmarket issues for regulated industry. Carole earned her engineering degrees from Johns Hopkins University and Loyola University of Maryland.