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FDA Issues Final Guidance on Electromagnetic Compatibility of Medical Devices Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff. This final guidance provides details about the information that should be included in premarket submissions to show EMC for electrically powered medical devices and medical devices with electrical or electronic functions. The Final Guidance: - Will replace the 2016 final guidance: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices
- 1 year after the publication of this final guidance for in vitro diagnostics (IVD).
- 60 days after the publication of this final guidance for other device types.
- Provides recommendations on EMC information and testing that should be included in a premarket submission.
- Helps manufacturers and FDA staff use the FDA-recognized standards for EMC.
- Helps streamline the review process for FDA staff and industry.
Version 2 of the non-IVD eSTAR will contain new EMC content and will be available for use during the 60-day implementation period. Version 1.2 of the non-IVD eSTAR will remain available for use until the 60-day implementation period ends. After the 60-day implementation period, Version 1.2 of the non-IVD eSTAR will be retired. Version 1.2 of the IVD eSTAR will be replaced with Version 1.3 upon guidance publication and will not contain new EMC content. The IVD eSTAR will be updated again with new EMC content before the 1-year implementation period ends. Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education. | 
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