Webinar - Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices
February 2, 2023
- February 2, 2023
- 1:00 PM - 2:00 PM ET
On February 2, 2023, the U.S. Food and Drug Administration (FDA) hosted 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:
- Clarified recommendations for electromagnetic compatibility information to include in an IVD premarket submission.
- Helped manufacturers and FDA staff use the FDA-recognized standards and partially recognized standards for the evaluation of electromagnetic compatibility of IVDs.
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.
The presentation, printable slides, and transcript are available at CDRH Learn under “In Vitro Diagnostics.”
If you have questions about this guidance document, please contact email@example.com. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at firstname.lastname@example.org, 1-800-638-2041, or 301-796-7100.