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RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises
The US Food and Drug Administration (FDA) regulates medical devices (MD), which are predicated on a concoction of economic and policy forces (e.g., supply/demand, crises, patents), under primarily two administrative circuits: premarketing notifications (PMN) and Approvals (PMAs). This work considers...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer International Publishing
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8382110/ https://www.ncbi.nlm.nih.gov/pubmed/34426954 http://dx.doi.org/10.1007/s43441-021-00334-4 |
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author | Daizadeh, Iraj |
author_facet | Daizadeh, Iraj |
author_sort | Daizadeh, Iraj |
collection | PubMed |
description | The US Food and Drug Administration (FDA) regulates medical devices (MD), which are predicated on a concoction of economic and policy forces (e.g., supply/demand, crises, patents), under primarily two administrative circuits: premarketing notifications (PMN) and Approvals (PMAs). This work considers the dynamics of FDA PMNs and PMAs applications as an proxy metric for the evolution of the MD industry, and specifically seeks to test the existence [and, if so, identify the length scale(s)] of economic/business cycles. Beyond summary statistics, the monthly (May, 1976 to December, 2020) number of observed FDA MD Applications are investigated via an assortment of time series techniques (including: discrete wavelet transform, running moving average filter, complete ensemble empirical mode with adaptive noise decomposition, and Seasonal Trend Loess decomposition) to exhaustively seek and find such periodicities. This work finds that from 1976 to 2020, the dynamics of MD applications are (1) non-normal, non-stationary (fractional order of integration < 1), non-linear, and strongly persistent (Hurst > 0.5); (2) regular (non-variance), with latent periodicities following seasonal, 1-year (short-term), 5–6 year (Juglar; mid-term), and a single 24-year (Kuznets; medium-term) period (when considering the total number of MD applications); (3) evolving independently of any specific exogenous factor (such as the COVID-19 crisis); (4) comprised of two inversely opposing processes (PMNs and PMAs) suggesting an intrinsic structural industrial transformation occurring within the MD industry; and, (6) predicted to continue its decline (as a totality) into the mid-2020s until recovery. Ramifications of these findings are discussed. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s43441-021-00334-4. |
format | Online Article Text |
id | pubmed-8382110 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-83821102021-08-23 RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises Daizadeh, Iraj Ther Innov Regul Sci Original Research The US Food and Drug Administration (FDA) regulates medical devices (MD), which are predicated on a concoction of economic and policy forces (e.g., supply/demand, crises, patents), under primarily two administrative circuits: premarketing notifications (PMN) and Approvals (PMAs). This work considers the dynamics of FDA PMNs and PMAs applications as an proxy metric for the evolution of the MD industry, and specifically seeks to test the existence [and, if so, identify the length scale(s)] of economic/business cycles. Beyond summary statistics, the monthly (May, 1976 to December, 2020) number of observed FDA MD Applications are investigated via an assortment of time series techniques (including: discrete wavelet transform, running moving average filter, complete ensemble empirical mode with adaptive noise decomposition, and Seasonal Trend Loess decomposition) to exhaustively seek and find such periodicities. This work finds that from 1976 to 2020, the dynamics of MD applications are (1) non-normal, non-stationary (fractional order of integration < 1), non-linear, and strongly persistent (Hurst > 0.5); (2) regular (non-variance), with latent periodicities following seasonal, 1-year (short-term), 5–6 year (Juglar; mid-term), and a single 24-year (Kuznets; medium-term) period (when considering the total number of MD applications); (3) evolving independently of any specific exogenous factor (such as the COVID-19 crisis); (4) comprised of two inversely opposing processes (PMNs and PMAs) suggesting an intrinsic structural industrial transformation occurring within the MD industry; and, (6) predicted to continue its decline (as a totality) into the mid-2020s until recovery. Ramifications of these findings are discussed. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s43441-021-00334-4. Springer International Publishing 2021-08-23 2022 /pmc/articles/PMC8382110/ /pubmed/34426954 http://dx.doi.org/10.1007/s43441-021-00334-4 Text en © The Drug Information Association, Inc 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic. |
spellingShingle | Original Research Daizadeh, Iraj RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises |
title | RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises |
title_full | RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises |
title_fullStr | RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises |
title_full_unstemmed | RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises |
title_short | RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises |
title_sort | retracted article: seasonal and secular periodicities identified in the dynamics of us fda medical devices (1976–2020): portends intrinsic industrial transformation and independence of certain crises |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8382110/ https://www.ncbi.nlm.nih.gov/pubmed/34426954 http://dx.doi.org/10.1007/s43441-021-00334-4 |
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