Joint Graduate School of Tokyo Women's Medical University and Waseda University (TWIns), Cooperative Major in Advanced Biomedical Sciences, Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan.
Joint Graduate School of Tokyo Women's Medical University and Waseda University (TWIns), Cooperative Major in Advanced Biomedical Sciences, Graduate School of Advanced Science and Engineering, Waseda University, c/o UMEZU Lab, 2-2 Wakamatsucho, Shinjukuku, Tokyo, 162-480, Japan.
Ther Innov Regul Sci. 2021 Jul;55(4):807-817. doi: 10.1007/s43441-021-00276-x. Epub 2021 Apr 12.
The developer and sponsor of new combination products in US needs to forecast which classification and designation to the regulatory scheme of drug, biological product, or device 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 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.
We searched the website of the FDA on 15 November, 2020 to identify the regulatory scheme of the FDA's 129 capsular decision cases of device-drug and device-biologics combination products and other publicly available cases the FDA designated to the drug/biologic or device regulatory scheme.
By introducing a new definition for primary intended use (PIU) by developers and sponsors extracted from the classification factors of primary mode of action (PMOA), we developed new visualization models of the designation pathway and two-dimensional group categorization. And applying these models to the cases the FDA designated, we proposed a new group categorization of combination products while focusing on the device component function.
The new visualization models with PIU and PMOA and the new group categorization focusing on the device component function proposed in this study may increase predictability and acceptability of the classification of newly developed combination products into the regulatory scheme of drug, biological product, and device, for innovators, developers, and sponsors.
美国新组合产品的开发者和赞助商需要预测新产品需要向美国食品和药物管理局（FDA）的药物、生物制品或器械监管方案进行哪种分类和指定。为了提高创新者、开发者和赞助商对新组合产品指定的可预测性和可接受性，并鼓励新组合产品的开发和早期获得，我们提出了新的指定途径和二维分组分类的可视化模型。
我们于 2020 年 11 月 15 日在 FDA 网站上搜索，以确定 FDA 对 129 个器械-药物和器械-生物制品组合产品的 129 个胶囊决策案例以及其他公开的 FDA 指定药物/生物制品或器械监管方案的案例的监管方案。
通过引入开发者和赞助商从主要作用模式（PMOA）的分类因素中提取的主要预期用途（PIU）的新定义，我们开发了指定途径和二维分组分类的新可视化模型。并将这些模型应用于 FDA 指定的案例，我们提出了一种新的组合产品分组分类，同时重点关注器械组件功能。
本研究提出的基于 PIU 和 PMOA 的新可视化模型以及重点关注器械组件功能的新分组分类，可能会提高创新者、开发者和赞助商对新开发的组合产品分类到药物、生物制品和器械监管方案的可预测性和可接受性。
