FCC clarifies regulations on medical devices that use radiofrequency

The Federal Communications Commission said that investigational devices that employ radiofrequency can receive reimbursement to cover the costs of a clinical trial, like other devices. These devices, which include several ablation catheters, fall under the purview of the FCC's Experimental Radio Service market trial rule. "The FCC clarified that the exception for ERS market trials includes cost recovery under FDA rules. Medical testing licensees conducting clinical trials may therefore recover costs to the extent permitted by the ERS market trial rule, but reimbursement is not permitted for an ERS product development trial," write Mintz Levin attorneys in a legal brief. More

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