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Medical Devices and the Public's Health
Language: en
Pages: 318
Authors: Institute of Medicine
Categories: Medical
Type: BOOK - Published: 2011-11-25 - Publisher: National Academies Press

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Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In
Public Health Effectiveness of the FDA 510(k) Clearance Process
Language: en
Pages: 132
Authors: Institute of Medicine
Categories: Medical
Type: BOOK - Published: 2011-06-10 - Publisher: National Academies Press

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The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of t
Public Health Effectiveness of the FDA 510(k) Clearance Process
Language: en
Pages: 141
Authors: Institute of Medicine
Categories: Medical
Type: BOOK - Published: 2010-10-04 - Publisher: National Academies Press

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The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its asse
Medical Device Safety
Language: en
Pages: 278
Authors: G.R Higson
Categories: Medical
Type: BOOK - Published: 2001-10-29 - Publisher: CRC Press

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Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical devic
Innovation and Protection
Language: en
Pages: 295
Authors: I. Glenn Cohen
Categories: Law
Type: BOOK - Published: 2022-04-07 - Publisher: Cambridge University Press

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A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.