Section 3038 of the 21st Century Cures Act applies Hatch-Waxman rules to certain drug-device combination products, addressing the regulatory pathway for devices that incorporate already approved drugs.
The Hatch-Waxman Act, named for Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), was approved in 1984. It was designed to make it easier for generic drugs to enter the market by requiring manufacturers to submit an abbreviated new drug application and prove their drug’s bioequivalence to the original branded drug. This meant generic drug makers would not have to endure the laborious and costly process of clinical studies.
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