Public health effectiveness of the FDA 510(k) clearance process : balancing patient safety and innovation : workshop report

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...

Descripción completa

Detalles Bibliográficos
Autor principal: Institute of Medicine (U.S.).
Autores Corporativos: Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process (-), Institute of Medicine (U.S.). Board on Population Health and Public Health Practice
Otros Autores: Wizemann, Theresa (-)
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press 2010.
Edición:1st ed
Materias:
United States. > Food and Drug Administration.
Public health > Standards > United States > Congresses.
Public health > United States > Congresses.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622293806719
Tabla de Contenidos:
  • ""Front Matter""; ""Reviewers""; ""Contents""; ""Abbreviations""; ""1 Introduction""; ""2 Legislative History of the Medical Device Amendments of 1976""; ""3 Premarket Notification""; ""4 The Medical Device Industry Innovation Ecosystem""; ""5 The Global Framework for Regulation of Medical Devices""; ""6 Public Comments""; ""Appendix A: Workshop Agenda""; ""Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers""; ""Appendix C: Premarket Notification: A Key Element of US Medical Device Regulation--Larry Kessler and Philip J. Phillips""
  • ""Appendix D: Impact of the Regulatory Framework on Medical Device Development and Innovation--David W. Feigal, Jr.""

Ejemplares similares