Medical devices and the public's health : the FDA 510(k) clearance process at 35 years /

"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 recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective device...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press, ©2011.
Temas:
Medical instruments and apparatus.
Medical instruments and apparatus > Safety regulations > United States.
Product safety > Law and legislation > United States.
United States Food and Drug Administration
Device Approval > standards
Equipment Safety > standards
Device Approval > legislation & jurisprudence
Device Approval
Product Surveillance, Postmarketing > methods
Equipment and Supplies
Médecine > Appareils et instruments.
Médecine > Appareils et instruments > Sécurité > Règlements > États-Unis.
MEDICAL > Allied Health Services > Medical Technology.
Medical instruments and apparatus
Medical instruments and apparatus > Safety regulations
Product safety > Law and legislation
United States
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Introduction
  • Key medical-device legislative and regulatory actions
  • Components of US medical-device regulation
  • The 510(k) clearance process
  • Postmarketing surveillance, compliance, and enforcement
  • External factors that affect the medical-device regulatory system
  • Conclusions and recommendations
  • A history of medical-device legislation and regulation in the United States.

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