The U.S. Food and Drug Administration (FDA) has issued final guidance in supporting claims of electromagnetic compatibility (EMC) of medical devices.
The document is recommended for use in conjunction with consensus standards, as well as other FDA guidance documents pertaining to specific devices.
Typically, the FDA reviews EMC information based on the risk of device malfunction and/or degradation if the device is exposed to electromagnetic interference by other devices near its intended electromagnetic environment. The proliferation of smartphones, wearables, home appliances, and other electronic devices poses a threat to safe performance of medical devices, and the FDA wants manufacturers to follow established standards and guidance documents to mitigate risks.
Manufacturers are recommended to follow device-specific guidance, such as one issued for Infusion Pumps Total Product Life Cycle, and cross-cutting guidances, such as Design Considerations for Devices Intended for Home Use.
In addition to following these FDA-recognized standards and guidance documents, and in order to support a claim of electromagnetic compatibility in premarket submissions, the FDA recommends in the final guidance that manufacturers include several items of information. The final guidance document applies to premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification [510(k)] submissions, investigational device exemption (IDE) applications, and de novo requests.
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