FDA Authorization of Medical Devices

• Autores: Jill Jin
• Localización: JAMA: the journal of the American Medical Association, ISSN 0098-7484, Vol. 311, Nº. 4, 2014, págs. 435-435
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • Similar to drugs, medical devices in the United States go through a review process by the US Food and Drug Administration (FDA) before they can be marketed for use in patients.

    A medical device is used to diagnose, prevent, or treat a medical disease or condition without having any chemical action on any part of the body. There are 3 classes of medical devices:

    Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs.

    Class II devices are intermediate-risk devices. Examples include computed tomography (CT) scanners or infusion pumps for intravenous medications.

    Class III devices are high-risk devices that are very important to health or sustaining life. Examples include pacemakers and deep-brain stimulators.