The U.S. Food and Drug Administration (FDA) has issued final guidance for medical device electromagnetic compatibility (EMC). The final guidance document details a number of primary components that are needed from U.S. manufacturers in order to obtain premarket clearance or approval for supporting claims of medical device EMC.
Proof of EMC ensures that a device is able to function in its intended environment without introducing excessive electromagnetic disturbance capable of causing electromagnetic interference with other electronically powered devices. In addition to following existing requirements and testing standards, registrants should include in their application the following information:
- Define the environment intended for use
- Provide summary report of testing to support EMC claims
- List of standards specifications met (including immunity test levels)
- Summary of device-specific tests including performance data and pass/fail criteria
- Device labeling and supporting documentation of compliance
- Detailed descriptions for changes, modifications, and any allowances as well as justifications in standard deviation
This guidance describes the type of information that should be provided, however it should be noted that additional information may be requested from the FDA Reviewer. View the final guidance document titled, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Device“.