Articles liés à FDA Oversight of Medical Devices: Efforts and Developments

FDA Oversight of Medical Devices: Efforts and Developments - Couverture rigide

 
9781622570898: FDA Oversight of Medical Devices: Efforts and Developments
Couverture rigide
ISBN 10 : 1622570898 ISBN 13 : 9781622570898
Editeur : Nova Science Publishers Inc, 2012

Synopsis

The FDA is responsible for overseeing the safety and effectiveness of medical devices sold in the United States. New devices are generally subject to FDA review via the 510(k) process, which determines if a device is substantially equivalent to another legally marketed device, or the more stringent pre-market approval process, which requires evidence providing reasonable assurance that the device is safe and effective. This book examines whether the FDA is sufficiently meeting the performance goals and whether devices are reaching the market in a timely manner.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Éditeur
Nova Science Publishers Inc
Date d'édition
2012
Langue
anglais
ISBN 10 
1622570898
ISBN 13 
9781622570898
Reliure
Relié
Numéro d'édition
1
Nombre de pages
150
Éditeur
Hill Matthew W, Torres Daniel E
Coordonnées du fabricant
non disponible
Personne responsable
non disponible