How 21st Century Cures Act Affects Combination Products

By Shana Cyr and Tom Irving (June 20, 2017, 5:19 PM EDT) -- In 2016, Congress enacted Section 3038 of the 21st Century Cures Act[1] to amend the portions of the Federal Food, Drug and Cosmetic Act (FDCA)[2] relating to the important and growing category of medical products that is combination products. Combination products include two or more regulated components (i.e., drug-device, biologic-device, drug-biologic or drug-device-biologic). Their regulation is complex because, in addition to many combination products involving new and complicated technologies, their components are subject to different premarket review pathways and regulations. According to the U.S. Food and Drug Administration, these "[d]ifferences ... can impact the regulatory processes for all aspects of product development and management."[3]...

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