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New Visualization Models of Designation Pathway and Group Categorization of Cell-Device and Protein-Device Combination Products in the United States

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Abstract

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.

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Data Availability

All data relevant to this study are publicly available on the FDA and the Alliance for Regenerative Medicine websites. Capsular Descriptions of Jurisdictional Determinations, (https://www.fda.gov/CombinationProducts/JurisdictionalInformation/RFDJurisdictionalDecisions/default.htm). Available Products, The Alliance for Regenerative Medicine (ARM), (https://alliancerm.org/available-products/).

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Acknowledgements

The authors would like to thank Professor Masayuki Yamato (Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University, Tokyo), Professor Kiyotaka Iwasaki (Cooperative Major in Advanced Biomedical Sciences, Graduate School of Advanced Science and Engineering, Waseda University), and Dr. Kyojiro Nambu (Waseda Research Institute for Science and Engineering, WASEDA University) for their advice and assistance.

Funding

This study is the independent work of the authors.

Author information

Authors and Affiliations

  1. Joint Graduate School of Tokyo Women’s Medical University, Graduate School of Advanced Science and Engineering, Waseda University (TWIns), Cooperative Major in Advanced Biomedical Sciences, Waseda University, c/o UMEZU Lab, 2-2 Wakamatsucho, Shinjukuku, Tokyo, 162-8480, Japan

    Nobuo Uemura & Mitsuo Umezu

  2. Waseda Institute for Medical Regulatory Science, Waseda University, Tokyo, Japan

    Hiroshi Kasanuki

  3. The Department of Integrative Bioscience and Biomedical Engineering, Graduate School of Waseda University, Tokyo, Japan

    Mitsuo Umezu

Authors
  1. Nobuo Uemura
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  3. Mitsuo Umezu
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Contributions

The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. Professor Hiroshi Kasanuki, M.D., Waseda Institute for Medical Regulatory Science, Waseda University, Tokyo, and Professor Mitsuo Umezu, Ph.D., Department of Integrative Bioscience and Biomedical Engineering, Graduate School of Waseda University, Tokyo, discussed and worked with the corresponding author to conceive and design the study and analytical methods, and supervised and revised the findings of this study. All the authors discussed the results and contributed to the final manuscript. Each author approved the submitted version of the manuscript and agreed to be accountable for all aspects of the work by ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Professor Masayuki Yamato, Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University, Tokyo, Professor Kiyotaka Iwasaki, Cooperative Major in Advanced Biomedical Sciences, Graduate School of Advanced Science and Engineering, Waseda University, and Dr. Kyojiro Nambu, Waseda Research Institute for Science and Engineering, Waseda University, contributed by providing comments and assistance in developing the design and analytical methods of this study.

Corresponding author

Correspondence to Nobuo Uemura.

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Uemura, N., Kasanuki, H. & Umezu, M. New Visualization Models of Designation Pathway and Group Categorization of Cell-Device and Protein-Device Combination Products in the United States. Ther Innov Regul Sci 55, 1199–1213 (2021). https://doi.org/10.1007/s43441-021-00307-7

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