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Fda Regulation of Medical Devices, Including the Status of Breast Implants: Joint Hearing Before the Subcommittee on Human Resources and ... Natural Resources, and Regulatory Affair - Softcover
Synopsis
Excerpt from Fda Regulation of Medical Devices, Including the Status of Breast Implants: Joint Hearing Before the Subcommittee on Human Resources and Intergovernmental Relations and the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight
There is a tragic irony to the history of breast implants. The 1976 device amendments to the Food, Drug and Cosmetic Act brought added protections and assurances of safety to users of new medical devices, but to patients who had or who would need breast implants, the application of the device law froze the technology in a regulatory and legal limbo from which it has yet to emerge.
Now, 19 years later, 19 years later, the very regulatory process designed to produce scientifically valid answers to questions of safety and risk seems unable to do so with regard to breast im plants. We need to know when this tragic uncertainty will end.
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This book is a reproduction of an important historical work. Forgotten Books uses state-of-the-art technology to digitally reconstruct the work, preserving the original format whilst repairing imperfections present in the aged copy. In rare cases, an imperfection in the original, such as a blemish or missing page, may be replicated in our edition. We do, however, repair the vast majority of imperfections successfully; any imperfections that remain are intentionally left to preserve the state of such historical works.
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- PublisherForgotten Books
- Publication date2018
- ISBN 10 1334801029
- ISBN 13 9781334801020
- BindingPaperback
- LanguageEnglish
- Number of pages218
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Fda Regulation of Medical Devices, Including the Status of Breast Implants
Print on DemandSeller: Forgotten Books, London, United Kingdom
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Paperback. Condition: New. Print on Demand. This book investigates the complexities of FDA regulation of medical devices in the United States, particularly concerning silicone gel breast implants. It examines the evolution of the FDA's approach, especially since the 1976 device amendments to the Food, Drug, and Cosmetic Act brought added protections and assurances of safety to users. The author explores crucial questions surrounding the safety and efficacy of these devices, and the impact that the FDA's handling of breast implants has had on the development of new medical devices and the availability of biomaterials. The book also analyzes the FDA's risk assessment process, determining the factors that are weighed in the quantification and evaluation of the benefits and risks of medical devices and biomaterials. This book provides a balanced analysis of a critical public health issue, shedding light on the FDA's role in ensuring the safety and effectiveness of medical devices while also promoting innovation and patient access to life-saving technologies. This book is a reproduction of an important historical work, digitally reconstructed using state-of-the-art technology to preserve the original format. In rare cases, an imperfection in the original, such as a blemish or missing page, may be replicated in the book. print-on-demand item. Seller Inventory # 9781334801020_0
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Fda Regulation of Medical Devices, Including the Status of Breast Implants Joint Hearing Before the Subcommittee on Human Resources and Natural Resources, and Regulatory Affair
Seller: PBShop.store US, Wood Dale, IL, U.S.A.
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PAP. Condition: New. New Book. Shipped from UK. Established seller since 2000. Seller Inventory # LX-9781334801020
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Fda Regulation of Medical Devices, Including the Status of Breast Implants Joint Hearing Before the Subcommittee on Human Resources and Natural Resources, and Regulatory Affair
Seller: PBShop.store UK, Fairford, GLOS, United Kingdom
Seller rating 5 out of 5 stars
PAP. Condition: New. New Book. Shipped from UK. Established seller since 2000. Seller Inventory # LX-9781334801020
Quantity: 15 available