Compliance News
EU Commission Issues Draft Guidelines for AI Systems
The Commission of the European Union (EU) is seeking public feedback on a proposed classification structure for high-risk systems utilizing artificial intelligence (AI).

According to a press release posted to the EU Commission’s website, the draft classification structure is intended to provide clarification on relevant provisions of the EU’s AI Act. The Act identifies two different types of AI systems, as follows: 1) AI systems embedded in products regulated under the Union’s harmonized legislation on product safety; and 2) AI systems that can significantly affect people’s health, safety, or fundamental rights in specific use cases listed in the Act.

The Commission says that the proposed classification structure detailed in its draft guidelines is intended to “help providers and deployers…assess whether their AI system is high-risk or not and what classification of high-risk their system would fall under.

FCC Publishes Annual Internet Access Services Status Report
The U.S. Federal Communications Commission (FCC) has recently released its annual report on access to Internet connections in the U.S., including information on the gap between current service levels and the benchmark Internet connection speeds recommended under the Commission’s National Broadband Plan.

According to the Commission’s report, titled “Internet Access Services: Status as of June 30, 2025,” approximately 88% of residential fixed Internet connections had a speed of at least 25 megabits per second (Mbps) downstream and 3 Mbps upstream by the end of the reporting period, from June 2021 through June 2025. These results easily surpass the target set in the National Broadband Plan of 3 Mbps downstream and 768 kilobits per second (kbps) upstream.

Without accounting for speed, the total number of Internet connections remains strong. As of June 30, 2025, there were nearly 560 million Internet connections operating at speeds over 200 kbps, slightly more than the 548 million recorded the previous year. And, once again, modern Internet connections continue to be dominated by mobile technologies, which account for more than (75%) of all Internet connections.

FCC Approves New Source for Verifying E911 Location Accuracy
The U.S. Federal Communications Commission (FCC) has approved a request from a wireless services provider to integrate date from a foreign satellite global positioning system (GPS) into Enhanced 911 (E911) location information.

The Commission granted a request submitted by T-Mobile USA, Inc. to use data from the European Union’s Global Navigation Satellite System, known as Galileo, as part of T-Mobile’s
911 emergency location services. T-Mobile made the request to “increase the availability, accuracy, and reliability” of its emergency location capabilities.

According to the Commission, “granting T-Mobile’s Request will assist with improving emergency response and saving lives, without increasing the exposure of T-Mobile devices to harmful interference.

Further, the Commission notes that the request meets requirements established by the Public Safety and Homeland Security Bureau to approve a previous request made by AT&T to use Galileo to enhance their wireless E911 location services.

FCC Announces New FM Radio Construction Permits Auction
In an effort to support increased competition in the radio industry, the U.S. Federal Communications Commission (FCC) has announced its plans to auction FM radio construction permits.

The Commission says its Auction 114 would launch in early 2027, making available 132 construction permits for currently vacant FM radio channels, including 100 permits not previously offered. This will also be the first FCC media auction utilizing the Commission’s Auction Application System, a new application and bidding system the FCC says is designed to improve efficiency and security.

“The FCC has a responsibility to ensure that spectrum is put to its highest and best use,” said FCC Chair Brendan Carr. “This FM auction is another step toward expanding opportunities for new voices and strengthening competition in the radio marketplace.”

FDA Updates List of Recognized Consensus Standards
The U.S. Food and Drug Administration (FDA) has recently updated its list of recognized voluntary standards that can be used to demonstrate compliance with particular requirements for the premarket review and authorization of medical devices.

The FDA’s recognition of national and international standards for compliance purposes has its roots in the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Acts which authorizes the agency to “recognize all of part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet premarket submission requirement.”

Since then, the FDA has recognized more than 1700 different standards for application in the premarket approval process, covering a wide range of medical specialties, including orthopedic applications, in vitro diagnostic testing, anesthesiology, obstetrics and gynecology, urology, and radiology.

As the FDA notes in its 2018 Guidance, titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,” “the use of consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products.”

FDA Releases Guidance on Human Factors Information in Marketing Submissions
The U.S. Food and Drug Administration (FDA) has released a final version of a Guidance Document intended to assist medical device manufacturers in identifying the relevant human factors-related information to include in marketing submissions to the agency.

The Guidance Document, “Content of Human Factors Information in Medical Devices Marketing Submissions,” details a risk-based framework that manufacturers and FDA staff can use to determine which information related to a device’s human factors characteristics should be included in premarket notifications (510(k)s), De Novo requests, premarket approval applications (PMAs) and humanitarian device exemption (HDE) applications.

The FDA says that the use of the information in this Guidance Document should be used in conjunction with the FDA’s guidance, titled “Applying Human Factors and Useability Engineering to Medical Devices.”

As a reminder, guidance documents issued by the FDA are not a substitute for applicable laws and regulations and are intended solely to provide information on the agency’s current perspective.

Share this story: