On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the regulations to enhance consistency with the 21st Century Cures Act (the Cures Act) and other guidance that has been released since the regulations were last amended, and to reflect accurately agency and industry experience in addressing combination product designations.