Cargando…
New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions
OBJECTIVE: 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 predictabilit...
Autores principales: | , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238755/ https://www.ncbi.nlm.nih.gov/pubmed/33844189 http://dx.doi.org/10.1007/s43441-021-00276-x |
_version_ | 1783714964997931008 |
---|---|
author | Uemura, Nobuo Kasanuki, Hiroshi Umezu, Mitsuo |
author_facet | Uemura, Nobuo Kasanuki, Hiroshi Umezu, Mitsuo |
author_sort | Uemura, Nobuo |
collection | PubMed |
description | OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSIONS: 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. |
format | Online Article Text |
id | pubmed-8238755 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-82387552021-07-13 New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions Uemura, Nobuo Kasanuki, Hiroshi Umezu, Mitsuo Ther Innov Regul Sci Original Research OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSIONS: 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. Springer International Publishing 2021-04-12 2021 /pmc/articles/PMC8238755/ /pubmed/33844189 http://dx.doi.org/10.1007/s43441-021-00276-x Text en © The Drug Information Association, Inc 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Original Research Uemura, Nobuo Kasanuki, Hiroshi Umezu, Mitsuo New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions |
title | New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions |
title_full | New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions |
title_fullStr | New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions |
title_full_unstemmed | New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions |
title_short | New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions |
title_sort | new visualization models of designation pathway and group categorization of device–drug and device–biologic combination products classification in the united states: analysis of fda capsular decisions |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238755/ https://www.ncbi.nlm.nih.gov/pubmed/33844189 http://dx.doi.org/10.1007/s43441-021-00276-x |
work_keys_str_mv | AT uemuranobuo newvisualizationmodelsofdesignationpathwayandgroupcategorizationofdevicedruganddevicebiologiccombinationproductsclassificationintheunitedstatesanalysisoffdacapsulardecisions AT kasanukihiroshi newvisualizationmodelsofdesignationpathwayandgroupcategorizationofdevicedruganddevicebiologiccombinationproductsclassificationintheunitedstatesanalysisoffdacapsulardecisions AT umezumitsuo newvisualizationmodelsofdesignationpathwayandgroupcategorizationofdevicedruganddevicebiologiccombinationproductsclassificationintheunitedstatesanalysisoffdacapsulardecisions |