FDA Offered FCC Advice on Medical Devices Before RF Proposal by Pai
The FDA offered the FCC advice on medical and other devices that operate on frequencies not covered by FCC rules, in an April letter, posted by the FCC Monday. “We agree that with the increase in technology that uses frequencies…
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below 300 kHz and even below 100 kHz, setting human exposure limits below 300 kHz and 100 kHz would better ensure the protection of the general public,” said the letter posted in docket 13-84. The biological response to frequencies below 300 kHz is “complex,” the letter said: “At the lower end of this range, electrostimulation (nerve stimulation) and induced currents predominate; at the upper end, heating is the predominant effect.” Current guidelines by IEEE and the International Commission on Non-Ionizing Radiation Protection don’t have identical specifications, the agency said. Both are “adequate to protect the general public in this frequency range,” FDA said: “Either of these would be an adequate model for the FCC to adopt for their rules below 300 kHz.” Chairman Ajit Pai recently circulated an item that keeps current limits in place, while making a few changes to update the rules (see 1908080061).