This bill amends Section 505(j) of the Federal Food, Drug, and Cosmetic Act to establish clearer requirements for the approval of generic drugs intended for use with a device , often referred to as combination products. These amendments empower the Secretary to determine what information is "required or appropriate" due to differences between the generic and listed drug-device combinations, including those related to the device itself. Specifically, the bill mandates that applications for generic drug-device combination products include relevant information to support that the new drug, when used with its device, can be expected to have the same clinical effect and safety profile as the listed drug-device combination. This information may encompass comparative and non-comparative data on the device's performance, compatibility of the new drug with the device, and delivery of the new drug. It also allows for comparative analyses of user interfaces and human factors studies to demonstrate equivalence despite differences. Furthermore, the bill establishes a new ground for refusing an application if the submitted information is insufficient to show that the generic drug for use with its device can be expected to have the same clinical effect and safety profile as the listed drug for use with its device. These changes aim to ensure rigorous evaluation of generic drug-device combination products.