An Overview of Food and Drug Administration Medical Device Legislation and Interplay with Current Medical Practices

Since the emergence of medical devices, legislation has been developed to allow the Federal Drug Administration (FDA) to oversee their development, marketing, and usage. This paper discusses the history of the FDA’s involvement in medical devices, current approval processes, and several case example...

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Detalles Bibliográficos
Autores principales: Schlauderaff, Abraham, Boyer, Kaleigh C
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cureus 2019
Materias:
Miscellaneous
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6615584/
https://www.ncbi.nlm.nih.gov/pubmed/31312553
http://dx.doi.org/10.7759/cureus.4627
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author Schlauderaff, Abraham
Boyer, Kaleigh C
author_facet Schlauderaff, Abraham
Boyer, Kaleigh C
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description Since the emergence of medical devices, legislation has been developed to allow the Federal Drug Administration (FDA) to oversee their development, marketing, and usage. This paper discusses the history of the FDA’s involvement in medical devices, current approval processes, and several case examples. Additionally, it discusses both short- and long-term effects with unexpected consequences to U.S. health care delivery.
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spelling pubmed-66155842019-07-16 An Overview of Food and Drug Administration Medical Device Legislation and Interplay with Current Medical Practices Schlauderaff, Abraham Boyer, Kaleigh C Cureus Miscellaneous Since the emergence of medical devices, legislation has been developed to allow the Federal Drug Administration (FDA) to oversee their development, marketing, and usage. This paper discusses the history of the FDA’s involvement in medical devices, current approval processes, and several case examples. Additionally, it discusses both short- and long-term effects with unexpected consequences to U.S. health care delivery. Cureus 2019-05-09 /pmc/articles/PMC6615584/ /pubmed/31312553 http://dx.doi.org/10.7759/cureus.4627 Text en Copyright © 2019, Schlauderaff et al. http://creativecommons.org/licenses/by/3.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Miscellaneous
Schlauderaff, Abraham
Boyer, Kaleigh C
An Overview of Food and Drug Administration Medical Device Legislation and Interplay with Current Medical Practices
title An Overview of Food and Drug Administration Medical Device Legislation and Interplay with Current Medical Practices
title_full An Overview of Food and Drug Administration Medical Device Legislation and Interplay with Current Medical Practices
title_fullStr An Overview of Food and Drug Administration Medical Device Legislation and Interplay with Current Medical Practices
title_full_unstemmed An Overview of Food and Drug Administration Medical Device Legislation and Interplay with Current Medical Practices
title_short An Overview of Food and Drug Administration Medical Device Legislation and Interplay with Current Medical Practices
title_sort overview of food and drug administration medical device legislation and interplay with current medical practices
topic Miscellaneous
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6615584/
https://www.ncbi.nlm.nih.gov/pubmed/31312553
http://dx.doi.org/10.7759/cureus.4627
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