Med Device Company Receives Partial Waiver of Part 15 Rules

The U.S. Federal Communications Commission (FCC) has granted a request from a medical device manufacturer for a partial waiver from Part 15 rules, giving the device manufacturer a path to achieve FCC certification.

According to an Order issued in late September, the waiver was issued in response to a petition from Sensible Medical Innovations Ltd., a New Jersey-based developer of a non-invasive medical imaging and diagnostic device used to provide lung fluid measurements for patients suffering from congestive heart failure. Specifically, the company requested a waiver from five separate sections of the Commission’s Part 15 rules, including the right to operate within a narrower operating bandwidth and a waiver of radiated emissions limits for ultra-wide band (UWB) medical imaging systems.

In response to public comments filed with the Commission regarding the request for the waiver, Sensible supplied the FCC with additional technical information and modified its original waiver request. These additional filings apparently satisfied the Commission that the modified waiver request would pose minimum risk of harmful interference and that “there is good cause to grant Sensible’s request.”

Read the Commission’s Order in connection with Sensible Medical Innovation’s request for waiver.

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