Public health effectiveness of the FDA 510(k) clearance process balancing patient safety and innovation : workshop report
"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 assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balanc...
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Autores Corporativos: | , |
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Formato: | Libro electrónico |
Idioma: | Inglés |
Publicado: |
Washington, D.C. :
National Academies Press
2010.
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Edición: | 1st ed |
Materias: | |
Ver en Biblioteca Universitat Ramon Llull: | https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622293806719 |
Sumario: | "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 assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop."-- |
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Notas: | Description based upon print version of record. |
Descripción Física: | 1 online resource (141 p.) |
Bibliografía: | Includes bibliographical references. |
ISBN: | 9780309162906 9781282885707 9786612885709 9780309158503 |