Yesterday, the Federal Communications Commission (“FCC”) granted GE Healthcare (“GEHC”) a waiver of its equipment authorization rules to allow for the importation, marketing, and operation of certain medical devices that have yet to receive authorization under applicable FCC requirements. The GEHC devices at issue include bedside and wearable patient monitors; telemetry transmitters; antenna infrastructure; wireless sensors; diagnostic testing ECG analysis systems; mobile radiology equipment; and portable X-rays.
The FCC granted the waiver due to the “unprecedented strain” that the COVID-19 pandemic has placed on the U.S. healthcare system. In doing so, the FCC recognized that GEHC now has to rely on alternative component suppliers to maintain a robust supply chain of devices, and that doing so has and will continue to require GEHC to pursue and secure new or modified equipment authorizations under the FCC’s rules. By waiving these rules for a temporary period, subject to certain conditions, the FCC enabled GEHC to import, market, and operate these devices before they are fully authorized, thereby improving the speed at which GEHC can bring them to market.
The FCC’s order imposed certain conditions on the grant of the waiver, including that:
- GEHC continue to pursue testing for compliance with applicable rules, though GEHC can rely on non-accredited laboratories for such testing if it ensures that they use good engineering practices;
- the devices at issue be operated only on the premises of healthcare facilities (including field hospitals) at the direction of authorized healthcare providers;
- GEHC submit an equipment authorization application to the FCC within 180 days after initially marketing a device (based on the date the device was first distributed to a healthcare facility);
- each affected device include a label noting the waiver terms and its limitations;
- once a device receives authorization it be labeled in accordance with the FCC’s existing rules;
- the waiver be limited to 18 months, subject to extension upon a detailed showing that further relief is warranted; and
- GEHC maintain a list of all covered devices and the healthcare facilities to which they are distributed, and report on the status of those devices within 30 days of the order’s expiration.
Information about the specific rules that the FCC waived and its rationale for doing so follows.
Importation. The FCC’s rules permit entities to import 4,000 or fewer units of an unauthorized device that emits radiofrequency emissions for testing and evaluation purposes, provided it is not offered for sale or marketed. The FCC granted GEHC a waiver of this 4,000 unit limit along with the testing and evaluation requirement (and sale or marketing prohibition), provided GEHC limits the operation of these devices to healthcare facilities, performs limited compliance testing on them, and complies with the other conditions described above.
Marketing. The FCC’s rules permit the marketing of a pre-authorized device in the conceptual, development, design, or pre-production stage under certain circumstances. The FCC granted GEHC a waiver of the conceptual, development, design or pre-production stage requirement, permitting GEHC to market a broader array of devices so long as (in addition to the other conditions described above) the devices are marketed for a limited period of time, eventually receive authorization, and, if not, are tracked and disposed of or removed from the marketplace.
Operation. The FCC’s rules contain a general prohibition against operating a radiofrequency device prior to its authorization, subject to certain exceptions. One of those exceptions permits pre-authorization operation if the device is intended to operate under Parts 15, 18 or 95 of the FCC’s rules; complies with applicable rules, waivers of such rules, or rules that have been promulgated but have not yet taken effect; would be retrieved or rendered inoperable at the conclusion of its operation, and is operated for one of two purposes: at a trade show or exhibition (with appropriate disclosures), or during the developmental, design or pre-production states to evaluate performance or determine customer acceptability. Although the FCC’s order is not especially clear on this point, it appears that the FCC granted GEHC a waiver of the purposes requirement — that such operation be at a trade show or exhibition or during the developmental, design or pre-production states to evaluate performance or determine customer acceptability — provided the devices are operated on the premises of healthcare facilities at the direction of healthcare providers, and adhere to the other conditions described above.
It appears that yesterday’s waiver order was granted very quickly, within 24 calendar days of filing and without being docketed or being subject to a request for public comment. It is among a range of actions the FCC has taken over the past two months to address COVID-19 concerns expeditiously.