Purpose: The developer and sponsor of new cell-device and protein-device combination products in the United States needs to forecast which classification and designation to the regulatory scheme of biological products or devices would be required for the new products by the Food and Drug Administration (FDA). To improve the predictability and acceptability of the designation of new cell-device and protein-device combination products for innovators, developers, and sponsors, and to encourage the development and early access of new combination products, we proposed new visualization models of the designation pathway and group categorization.
Methods: We searched the website of the FDA and the Alliance for Regenerative Medicine (ARM) on May 3, 2021 to identify the regulatory scheme of the FDA's capsular decision cases of cell-device and protein-device combination products, and of the tissue-engineered products approved by the FDA.
Results: By introducing a new definition of the primary intended use (PIU) of developers and sponsors extracted from the classification factors of primary mode of action (PMOA), as well as drug-device and biologic-device combination products, we developed new visualization models of the designation pathway and the two-dimensional model of group categorization, and proposed a new group categorization of cell-device and protein-device combination products, focusing on the device component function.
Discussion: The new visualization models and the group categorization proposed in this study may increase the predictability and acceptability of the classification of newly developed cell-device and protein-device combination products to regulatory schemes in the US for innovators, developers, and sponsors.
Keywords: Cell; Classification; Combination product; Device; Protein; Regulatory scheme.
© 2021. The Drug Information Association, Inc.