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  5. Webinar – Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices - 02/02/2023
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar – Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices
February 2, 2023

Date:
February 2, 2023
Time:
1:00 PM - 2:00 PM ET

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Summary

On February 2, 2023, the U.S. Food and Drug Administration (FDA) will host a webinar for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices and respond to questions. 

During this webinar the FDA will:

  • Clarify recommendations for electromagnetic compatibility information to include in an IVD premarket submission.
  • Help manufacturers and FDA staff use the FDA-recognized standards and partially recognized standards for the evaluation of electromagnetic compatibility of IVDs.

Background

This final guidance, Electromagnetic Compatibility (EMC) of Medical Devices, was issued on June 6, 2022. This guidance document provides the FDA’s recommendations on testing to assess the electromagnetic compatibility of medical devices and information to include in the labeling. This guidance applies to medical devices, including IVDs, and accessories that are electrically powered or have functions or sensors that are implemented using electrical or electronic circuitry. The recommendations are intended to promote consistency and facilitate efficient review of electromagnetic compatibility in device submissions.

Webinar Details

Registration is not necessary.

Date: February 2, 2023

Time: 1:00 - 2:00 p.m. ET

Please dial in 15 minutes before to the start of the call to allow time to connect.

Please click the link below to join the webinar:  https://fda.zoomgov.com/j/1603906127?pwd=cThwZnNtRC9CaWtPV0FTc0JxaHVMQT09

Passcode: tB^7Hq

Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining the webinar by phone only.

Webinar Materials

After the webinar, the presentation, printable slides, and transcript will be available at CDRH Learn under “In Vitro Diagnostics.”

If you have questions about this guidance document, please contact seth.seidman@fda.hhs.gov. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

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