FDA Issues Draft Guidance on Electromagnetic Compatibility of Medical Devices
Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Electromagnetic Compatibility (EMC) of Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff.
This draft guidance outlines information that should be included in pre-market submissions to demonstrate electromagnetic compatibility (EMC) for electrically powered medical devices and medical devices with electrical or electronic functions.
Note: This guidance is not for implementation at this time.
Submit comments on this draft guidance
This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2015-D-3787.
Questions?
If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.
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