Electromagnetic Compatibility (EMC) of Medical Devices

June 7, 2022

A monitoring laboratory with an MRI machine behind the glass.

Guidance Document

June 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 in vitro diagnostics, 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.

FDA recognizes and anticipates that the Agency and industry may need up to 1 year to perform activities to operationalize the policies within the guidance, only for in vitro diagnostic products. Since this guidance generally reflects current practice for the assessment of EMC for other device types, but some activities to fully operationalize the policies are needed (e.g., updates to eSTAR), FDA intends to implement this guidance 60 days after issuance for device types within the scope of this guidance, excluding in vitro diagnostic products. If new information regarding electromagnetic compatibility as outlined in this guidance is not included in a premarket submission for an in vitro diagnostic received by FDA before or up to 1 year after the publication of this guidance or for other device types within the scope of this guidance before or up to 60 days after the publication of this guidance, CDRH staff does not generally intend to request such information during the review of the submission. CDRH does, however, intend to review any such information if submitted.

Download the Final Guidance Document

Read the Federal Register Notice

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.


Several filename extensions shown in an array of icons.

June 27, 2022

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry

Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...

Pages of a calendar flying away.

April 27, 2022

Providing Submissions in Electronic Format — Postmarketing Safety Reports

GUIDANCE DOCUMENT April 2022 This guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for...

Gloved hands holding up vials over a laptop keyboard.

May 16, 2022

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision

Guidance for Industry May 2022 Today, FDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” Specifically, this...