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FCC Tweaks Experimental Radio Service Rules in Win for Medtronic

The FCC released an order making an additional change to its Part 5 experimental radio service (ERS) rules, which were substantially updated in a May 2013 order. In that order, the FCC decided not to expand the eligibility for medical…

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testing experimental licenses to entities other than hospitals and health care institutions. Last year, a Further NPRM examined changes to the rules (see 1507080050). Medtronic pressed the FCC to act on new rules that would make medical device manufacturers eligible for medical testing experimental licenses (see 1510290037). The medical device maker said changing the rules would help “ameliorate the disparity between those medical device manufacturers eligible for Medical Testing Experimental Licenses and those eligible for Program Experimental Licenses." The latest order said only Medtronic filed comments on the rule change. Nonetheless, commissioners agreed: “Because clinical trials conducted under the medical testing experimental license or as a market trial may be tested in these restricted bands, there is no reason to impose greater frequency restrictions on program licensees conducting basic research on the same devices,” the FCC said. “This rule change also will establish parity between all qualified medical device manufacturers and developers -- whether they are health care institutions or medical device manufacturers -- as to permissible frequencies of operation for conducting basic research and clinical trials with RF-based medical devices.”