compliance news
FCC Affirms $2.3 Million Fine for Pirate Radio Broadcasting
The U.S. Federal Communications Commission (FCC) has affirmed a $2.3 million financial penalty against two brothers for illegal pirate radio broadcasts in Queens, NY.

According to a Forfeiture Order issued by the Commission, Cesar Ayora and his brother Luis Angel Ayora “engaged in the longstanding illicit operation of an unauthorized radio station known as Radio Impacto 2,” in violation of the provisions of the Communications Act, and have been ordered to pay $2,316,034.

The Ayoras were originally recipients this past March of a Notice of Apparently Liability for Forfeiture (NAL) in connection with their years-long pirate radio operations, following extensive surveillance by field agents of the New York Office of the FCC’s Enforcement Bureau. In that NAL, the Commission calculated a proposed forfeiture of over $21 million but reduced the amount to $2,316,034 based on statutory limits.

However, the Ayoras failed to file a response to the NAL, hence the issuance of the Forfeiture Order.

FDA Issues Guidance on Electronic Submissions of 510(k)s
The U.S. Food and Drug Administration (FDA) has released its final guidance on premarket notification (510(k)) submissions by electronic format.

The Guidance, “Electronic Submission Template for Medical Device 510(k) Submissions,” provides a detailed explanation of the structure of the agency’s current eSTAR 510(k) electronic submission template, along with a thorough description of the kind of information expected for each individual template listing (e.g., “device description,” “consensus standards,” “predicates and substantial equivalence,” “labeling,” etc.).

Where appropriate, the Guidance also lists the applicable standards and other documents that device developers should use in assessing the compliance of their device with the FDA’s requirements.

Guidance documents issued by the FDA and other agencies are intended solely to provide insight into the current thinking of regulators and should be viewed only as recommendations and not requirements.

EU Commission Extends Date of Expanded Radio Equipment Requirements
The Commission of the European Union (EU) has extended the effective date of its expanded application of the essential requirements of its Radio Equipment Directive (2014/53/EU, also known as RED).

Published in the Official Journal of the European Union, Delegated Regulation (EU) 2023/2444 extends until August 2025 the expanded application of the RED detailed in Delegated Regulation (EU) 2022/30. That Delegated Regulation includes the cybersecurity of internet-connected equipment under the scope of the RED and was originally scheduled to take effect in August 2024.

Internet-connected equipment specifically subject to the provisions of EU 2022/30, includes:

  • Radio equipment designed or intended exclusively for childcare;
  • Radio equipment covered under the scope of the EU’s Directive on the Safety of Toys (2009/48/EC);
  • Radio equipment designed or intended to be worn, strapped to, or hung from any part of the human body or incorporated into any clothing worn by humans, such as headwear, hand wear, or footwear;
  • Radio equipment that enables the holder or user to transfer money, monetary value, or virtual currency.
Internet-connected equipment expressly not included under the expanded scope of cybersecurity requirements detailed in the draft Delegated Regulation includes medical devices covered under the EU’s Medical Device Regulation (EU 2017/745) and the In Vitro Diagnostic Medical Device Regulation (EU 2017/746). Also excluded are internet-connected equipment and devices used in civil aviation applications (EU 2018/1139) and in automotive systems and components (EU 2019/2144).
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EU Commission Designates Six “Gatekeepers” Under Its Digital Markets Act
The Commission of the European Union (EU) has named six major digital platform companies as “gatekeepers” under the EU’s Digital Markets Act (DMA).

According to an EU Commission press release, Alphabet, Amazon, Apple, ByteDance, Meta, and Microsoft have received designations as gatekeepers. The EU defines gatekeepers as large digital platforms providing so-called core platform services, such as online search engines, app stores, and messaging services.

EU-designated gatekeeps are subject to Commission oversight and are required to comply with the obligations and prohibitions detailed in the DMA. Specifically, gatekeepers must:

  • Allow third parties to “inter-operate” on the gatekeeper’s digital platform;
  • Allow business users to access data generated from the use of the gatekeeper’s platform;
  • Provide companies advertising on their platform with the tools and information necessary to independently verify their advertising hosted by the gatekeeper; and
  • Allow businesses to promote their offers outside of the gatekeeper’s platform.
  • At the same time, gatekeepers cannot:
  • Provide preferential treatment to products and services offered by the gatekeeper itself;
  • Prevent consumers from linking up to businesses outside of their platforms;
  • Prevent users from uninstalling any pre-installed software or app if they wish to do so; and
  • Track end users outside of the gatekeeper’s platform services without receiving the consent of the end user.
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