Under the provisions of the “Preventing Illegal Radio Abuse Through Enforcement (PIRATE) Act,” the FCC now has the authority to levy fines against unauthorized radio operations of up to $100,000 per violation per day and $2 million in total. The rules cover not just illegal broadcasters themselves but also property owners and managers that house illegal broadcast operations on their premise or that knowingly facilitate those operations.
The final FCC rules under the PIRATE Act were published in the U.S. Federal Register on March 25th and took effect on April 26th.
In a press release issued by the FCC, the FCC named three carriers, China Unicom Americas, Pacific Networks, and ComNet, which it says are owned and controlled by the government of the People’s Republic of China.
In response to the substantial evolution of security threats in the past few years, the Commission has raised concerns about the vulnerability of Chinese state-owned enterprises to direct control by the government. Last year, the FCC requested that each of the three companies show cause why the Commission should not revoke their authorizations under its Section 214 authority.
Because each company failed to fully address the FCC’s concerns in their respective responses, the Commission decided that, consistent with national security interests, to begin proceedings to determine whether “present and future public interest, convenience, and necessity” justify the revocation of the authorizations previously granted to each company.
According to an article posted on the Drone DJ website, the upward radar device is based on a new technology developed by DJI, an established drone company based in Guangdong, China. It is described in the company’s FCC filing as “DXX – Part 15 Low Power Communication Device Transmitter,” which operates on the 24.15 GHz frequency.
An FCC test report of the device confirms the basic information contained in the Drone DJ website article, stating that the device is “an Upward Radar…(that) contains a 24 GHz compatible module enabling the user to detect the object from the blindside through a radar detector.”
According to a recent article in the Harvard Press, the town’s local newspaper, opposition is focused on a special permit requested by a contractor to AT&T to replace old radio equipment on one of the cell towers located within the town and replace it with more up-to-date technology. The company’s permit application filed with the town’s Planning Board says that the new equipment will not significantly change the appearance of the tower and would not generate any vibrations, noise, or fumes.
However, during a hearing at the Board’s February meeting, a number of residents expressed concerns about the increased potential for radiation stemming from the upgrade, as well as the dangers of 5G technology. According to the Harvard Press article, one resident claimed that “the FCC approval doesn’t mean anything because they aren’t doing any health studies, and if they are, they are swaying them in their favor.” Another resident implored members of the town’s Planning Board to read the arguments against 5G technologies posted on an anti-5G website.
Planning Board Chair Justin Brown, a trained nuclear scientist, reportedly took the opportunity during the hearing to explain the science behind electromagnetic radiation and why the cellphone communications technologies do not pose a risk. He also argued that the basis for the opposition on the part of some town residents was a 2018 study of the effect of radio waves on rats, a study Brown says was severely flawed in its design and its findings.
The Planning Board was expected to vote on the special permit request at recent meeting. As of this writing, there is no information regarding the Board vote. Stay tuned!
The Catalog of Regulatory Science Tools was assembled by the FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Laboratories (OSEL) and posted to the FDA’s website. The Catalog includes details on dozens of methods, computational models and simulations, and phantoms that medical device manufacturers can use to assess their devices for safety and performance.
The FDA says that the Catalog will be expanded and updated as new tools become available. Importantly, the agency also notes that the tools in the Catalog do not replace FDA-recognized standards or qualified medical device development tools.
In an Implementing Decision (EU) 2021/455, the Commission moved to replace the 2010 edition of EN 55024, Electromagnetic compatibility – Product family standard for audio, video, audio-visual and entertainment lighting control apparatus for professional use – Part 2: Immunity, with EN 55035: 2017, Electromagnetic compatibility of multimedia equipment – Immunity requirements.
The Implementing Decision also replaces the 2007 edition of EN 60947-5-2, Low-voltage switchgear and control gear – Part 5.2: Control circuit devices and switching elements – Proximity switches, with the edition of the standard issued in 2020.
The date of withdrawal for both EN 55024:2010 and EN 60947-5-2:2007 is mid-September 2022.
Biocompatibility assessment and testing are required for medical devices that come in direct or indirect contact with the human body to determine the potential for an adverse biological reaction to device component materials that could lead to injury or death.
The FDA’s new Biocompatibility Assessment Resource Center provides device manufacturers with a step-by-step approach that addresses: 1) biocompatibility basics; 2) evaluation endpoints; 3) test articles; and 4) test reports. The Resource Center also provides links to additional information regarding each of these steps.
The FDA’s Biocompatibility Resource Center is intended to supplement the FDA’s own guidance on biocompatibility, “Use of International Standard ISO 10993‑1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’.” The FDA also welcomes the submission of general questions about biocompatibility issues, which can be emailed to CDRH.Biocomp@fda.hhs.gov.
The Commission adopted the 2019 edition of ANSI C63.19, American National Standard Methods of Measurement Compatibility Between Wireless Communications Devices and Hearing Aids, as the standard to be used in assessing HAC-compatible handsets. The revised version of the standard incorporates volume control specifications consistent with HAC certification requirements that were scheduled to take effect on March 1st.
In addition to volume control specifications, ANSI C63.19-2019 also harmonizes its testing methodologies with current available international standards and applies to a wider range of frequencies.
In its Report and Order, the FCC provides for a two‑year transition period for manufacturers to adopt the requirements in the updated standard. It also extended the volume control deadline to match this transition period.