The Federal Communications Commission (FCC) granted GE Healthcare’s request for a waiver to allow the importation, marketing and operation of certain GE medical devices from new suppliers for use in healthcare facilities during the COVID-19 pandemic.
The action taken by the Commission will enable GE Healthcare to overcome disruptions in the medical device supply chain as it addresses the surge in demand for critical medical equipment. Without the waiver, many of GE’s devices that are sourced from new suppliers or that contain new components would have required prior FCC equipment certification, which would delay GE’s ability to provide medical facilities with the equipment needed to treat patients.
“The FCC is committed to doing everything in its power to help healthcare facilities treat patients during the coronavirus pandemic,” said FCC Chairman Ajit Pai. “This waiver will enable GE Healthcare to get new medical equipment into the field that will benefit healthcare professionals during this difficult time.”
The Order, which was issued by the Wireless Telecommunications Bureau and Office of Engineering and Technology, waives certain rules in parts 2, 15, 18 and 95 of the agency’s rules. It also requires GE Healthcare to test the devices prior to deployment and imposes a condition that GE Healthcare must obtain the required equipment certifications for all devices within 18 months or it will have to collect any unauthorized devices at the end of the waiver period.
