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.

Tags: COVID-19, FCC, Medical Devices, Radiofrequency, Waiver
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Yaron Dori has over 25 years of experience advising technology, telecommunications, media, life sciences, and other types of companies on their most pressing business challenges. He is a former chair of the firm’s technology, communications and media practices and currently serves on the…

Yaron Dori has over 25 years of experience advising technology, telecommunications, media, life sciences, and other types of companies on their most pressing business challenges. He is a former chair of the firm’s technology, communications and media practices and currently serves on the firm’s eight-person Management Committee.

Yaron’s practice advises clients on strategic planning, policy development, transactions, investigations and enforcement, and regulatory compliance.

Early in his career, Yaron advised telecommunications companies and investors on regulatory policy and frameworks that led to the development of broadband networks. When those networks became bidirectional and enabled companies to collect consumer data, he advised those companies on their data privacy and consumer protection obligations. Today, as new technologies such as Artificial Intelligence (AI) are being used to enhance the applications and services offered by such companies, he advises them on associated legal and regulatory obligations and risks. It is this varied background – which tracks the evolution of the technology industry – that enables Yaron to provide clients with a holistic, 360-degree view of technology policy, regulation, compliance, and enforcement.

Yaron represents clients before federal regulatory agencies—including the Federal Communications Commission (FCC), the Federal Trade Commission (FTC), and the Department of Commerce (DOC)—and the U.S. Congress in connection with a range of issues under the Communications Act, the Federal Trade Commission Act, and similar statutes. He also represents clients on state regulatory and enforcement matters, including those that pertain to telecommunications, data privacy, and consumer protection regulation. His deep experience in each of these areas enables him to advise clients on a wide range of technology regulations and key business issues in which these areas intersect.

With respect to technology and telecommunications matters, Yaron advises clients on a broad range of business, policy and consumer-facing issues, including:

  • Artificial Intelligence and the Internet of Things;
  • Broadband deployment and regulation;
  • IP-enabled applications, services and content;
  • Section 230 and digital safety considerations;
  • Equipment and device authorization procedures;
  • The Communications Assistance for Law Enforcement Act (CALEA);
  • Customer Proprietary Network Information (CPNI) requirements;
  • The Cable Privacy Act
  • Net Neutrality; and
  • Local competition, universal service, and intercarrier compensation.

Yaron also has extensive experience in structuring transactions and securing regulatory approvals at both the federal and state levels for mergers, asset acquisitions and similar transactions involving large and small FCC and state communication licensees.

With respect to privacy and consumer protection matters, Yaron advises clients on a range of business, strategic, policy and compliance issues, including those that pertain to:

  • The FTC Act and related agency guidance and regulations;
  • State privacy laws, such as the California Consumer Privacy Act (CCPA) and California Privacy Rights Act, the Colorado Privacy Act, the Connecticut Data Privacy Act, the Virginia Consumer Data Protection Act, and the Utah Consumer Privacy Act;
  • The Electronic Communications Privacy Act (ECPA);
  • Location-based services that use WiFi, beacons or similar technologies;
  • Digital advertising practices, including native advertising and endorsements and testimonials; and
  • The application of federal and state telemarketing, commercial fax, and other consumer protection laws, such as the Telephone Consumer Protection Act (TCPA), to voice, text, and video transmissions.

Yaron also has experience advising companies on congressional, FCC, FTC and state attorney general investigations into various consumer protection and communications matters, including those pertaining to social media influencers, digital disclosures, product discontinuance, and advertising claims.

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