FDA Issues a Draft Guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

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Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.

Facts About the Guidance
The MR environment presents unique safety hazards for patients and other persons with medical devices near or inside an MR system. This draft guidance, when finalized, is intended to:

  • Provide recommendations on testing for assessing the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment.
  • Identify test methods that address specific hazards and provide recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling.

Submit Comments on the Draft Guidance
This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2019-D-2837.

Questions?
If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.

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