Medical Innovation Exchange

FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices



The FDA is hosting a webinar on February 2 from 1:00-2:00pm ET for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices.

The FDA announced that during this webinar it 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.

The final guidance was issued on June 6, 2022. It provides the FDA’s recommendations on testing to assess the EMC of medical devices as well as 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.

Attendees do not need to pre-registration for the webinar. The link to attend is available here.

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