The drug and device industries must be prepared for sweeping changes to the status quo promised by the 21st Century Cures Act, according to one expert.

Combination products, for example, may see some of the largest impacts as sponsors take advantage of the act’s provisions to leave the drug category for the less-regulated device category, said Jim O’Reilly, a retired law professor at the University of Cincinnati College of Law, in a webinar hosted by FDAnews.

A major change to watch for is implementation of the law’s requirement that the FDA “shall not determine that the primary mode of action is that of a drug or biological product solely because the combination product has any chemical action within or on the human body,” he said. This is a significant shift from the “bright line” on drugs and devices the FDA has historically used in enforcement.