Recently, the U.S. Food and Drug Administration (FDA) has released a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of products for premarket submissions.
“FDA reviews these types of claims based on the risk of EMC malfunction or degradation of the device under review, and in accordance with industry standards,” Med Device Online reported.
According to Med Device Online, medical devices often operate in an environment that is increasingly crowded with potential sources of electromagnetic interference.
“FDA wants manufacturers to comply with updated standards for EMC to help ensure device performance and protect public safety,” Med Device Online added.
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