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FDA publishes draft Guidance on Testing and Labeling Devices in the MR Environment

  • Posted by: inetika
  • Category: GLOBAL NEWS

The US Food and Drug Administration (FDA) has issued a draft guidance document titled ‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Draft Guidance for Industry and Food and Drug Administration Staff’.

“This draft guidance document is anticipated to aid in consistency of reviews, testing, and MRI safety labeling across a variety of medical devices,” the agency explains. The guidance applies to all implanted devices, devices intended to enter the MR environment, and external devices carried by or attached to a patient, such as an external insulin pump.

Copies can be obtained from here.

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