U.S. FCC Grants Healthcare Waiver to Expedite Medical Equipment

In the midst of the COVID-19 pandemic, the U.S. Federal Communications Commission (FCC) has granted a temporary waiver for radio frequency (RF) certification of certain critical medical devices.

The FCC’s order, issued in mid-May by the Commission’s Wireless Telecommunications Bureau and Office of Engineering Technology, approves a request from GE Healthcare to allow the company to import, market and operate certain GE medical equipment from new suppliers for use in medical facilities and to temporarily bypass the FCC equipment certification process in order to get the devices to healthcare providers more quickly.

Specifically, the Order waives the requirement for RF certification for models of wearable and bedside patient monitors, diagnostic testing equipment and mobile radiology and portable x-ray equipment that has been produced, imported, distributed or marketed by GE Healthcare.

The operation of equipment bypassing the RF certification requirements would be limited to “health care facilities” and at the direction of “authorized health care providers.” Further GE Healthcare would be required to test the equipment prior to its actual deployment and to submit an equipment authorization application to an FCC-authorized telecommunications certification body (TCB) within 180 days of initially marketing of devices. Finally, the term of the Commission’s waiver is limited to not longer than 18 months.

Read the complete text of the FCC’s Order in connection with GE Healthcare.

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