compliance news
FCC Establishes Spectrum Management Principles for Transmitters, Receivers
The Policy Statement is based largely on proceedings held last year by the Commission
The U.S. Federal Communications Commission (FCC) has published a set of high-level principles that it says will guide its management of the electromagnetic spectrum in the future.

The FCC’s Policy Statement, “Principles for Promoting Efficient Use of Spectrum and Opportunities for New Services,” presents a framework designed to consider both transmitter and receiver components of wireless systems. The goal of the framework is reportedly to promote improved receiver performance as a key focal point in making more efficient use of the available spectrum and enabling new and advanced wireless technologies to be introduced to the market.

According to the FCC, the Policy Statement is based largely on proceedings held last year by the Commission, as well as research conducted by the FCC’s Technological Advisory Council.

FDA Releases Latest Third-Party Review Performance Report
The U.S. Food and Drug Administration (FDA) has published its most recent data on the performance of accredited third parties conducting primary reviews of medical devices under the Agency’s 510(k) process.

The FDA’s “Third Party Review Organization Performance Report” summarizes the activity of third parties accredited by the FDA’s Accredited Persons Program who completed at least five 510(k) submissions during the first six months of fiscal year 2023 (October 1, 2022, through March 31, 2023).

Created under the scope of the FDA Modernization Act of 1997, the FDA’s Accredited Persons Program is intended to improve the efficiency and timeliness of medical device 510(k) reviews and help speed market access for medical devices.

During the 6-month evaluation period, the FDA accepted 35 submissions from FDA-accredited third parties, with 24 (69%) ultimately receiving final decisions from the FDA, with 11 decisions pending by the conclusion of the evaluation period. Unlike prior review periods, none of the submissions made during the review period were withdrawn by the device manufacturer for unspecified reasons.

For those submissions receiving a final FDA decision, 96% were achieved within 30 calendar days, with an average FDA total review time of just 23 days. Average review times in the lowest 25th percentile of submissions were as low as 19 calendar days, while the maximum review time reached as long as 70 days.

FCC Launches Space Bureau
Recognizing our future reliance on space-based infrastructures to support the deployment of advanced telecommunications capabilities in underserved areas, the U.S. Federal Communications Commission (FCC) has announced the formation of a new Space Bureau within the agency.

According to a press release, the Space Bureau will “lead policy and licensing matters related to satellite and space-based communications and activities.” Specifically, the Bureau will conduct policy analysis and rulemakings, authorize satellite and earth station systems for space-based services, and streamline regulatory processes to enable operators to meet customer needs more effectively.

Most important, the Space Bureau will help foster the efficient use of scarce spectrum and orbital resources and serve as a liaison with other federal agencies and foreign government officials on issues related to space policy and governance.

In its press release, the FCC also announced the formation of a new Office of International Affairs (OIA). The OIA will take the lead in engaging with representatives of regulatory authorities in other global jurisdictions around the world and help facilitate future rulemakings and policies on international telecommunications issues.

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EU Commission Updates Regulation on Standby Energy Consumption of Electrical/Electronic Equipment
The Commission of the European Union (EU) has updated its ecodesign requirements applicable to electrical and electronic household and office equipment to address energy use in standby and off modes.

Published in the Official Journal of the European Union, Commission Regulation (EU) 2023/826 sets new, lower power consumption levels for electrical and electronic devices to reflect technological progress. The Regulation also expands the scope of products subject to these requirements, including motor-operated furniture such as standing desks and window blinds and curtains.

Here’s a summary of the energy usage requirements presented in the new Regulation:

  • From 2025 on, devices must not consume more than 0.5 Watts in standby or in off mode, or 0.8 Watts if they are in standby mode while displaying their status or other information;
  • From 2027 on, devices must not consume more than 0.5 Watts in Standby, 0.3 Watts in off mode, or 0.8 Watts if they are in standby mode while displaying their status or other information; and
  • From 2027 on, devices in network standby mode must not consume more than 2 to 7 Watts, depending on the product.
The Commission says that the updated energy consumption requirements will save an additional 4 terawatt-hour (TWh)/year of energy, with greenhouse gas emissions (GHG) emission reductions of 1.36 metric tons (MT) of carbon dioxide equivalent (CO2eq)/year by 2030.
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