compliance news
FCC Moves to Free Up More Spectrum for 5G Deployment
As part of its ongoing effort to free up spectrum for the nationwide deployment of 5G technology, the U.S. Federal Communications Commission (FCC) has proposed to allocate a portion of mid-band spectrum for 5G use.

The Commission’s Report and Order and Further Notice of Proposed Rulemaking lays the groundwork for making 100 megahertz of spectrum in the 3.45-3.55 GHz band available for 5G use. Specifically, the Report and Order adopts a 2019 FCC proposal to remove secondary, non-federal allocations from the 3.3-3.55 GHz band as a first step to facilitate spectrum sharing between federal incumbents and commercial operations.

The Further Notice of Proposed Rulemaking proposes: 1) allocation changes to the band to enable future commercial use; 2) coordination between future commercial users and federal incumbents that remain operational within the band; 3) relocation logistics for non-federal secondary users; and 4) technical, licensing and operating rules to foster a successful coordinator of band use between the parties.

FDA Issues Guidance Documents on Pilot Accreditation Scheme
The U.S. Food and Drug Administration (FDA) has issued three final guidance documents in support of a pilot program that would allow accredited testing laboratories to assess medical devices for compliance with certain FDA-recognized standards. The three final guidance documents issued by the FDA include:

  • “The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program”—This guidance describes how the Pilot accreditation program was designed and how accreditation bodies, testing laboratories and device manufacturers can participate in the program.
  • “Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program”—This guidance provides information specific to the basic safety and essential performance of standards in the Pilot program. Specifically, the guidance addresses which standards are eligible for inclusion in the Pilot, ASCA program specifications for those standards, and recommended premarket submission contents specific to those standards when testing is conducted by an ASCA-accredited testing laboratory.
  • “Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program—This guidance provides information on the biological evaluation of medical device standards and test methods in the ASCA Pilot. Similar to the previously referenced guidance, this guidance discusses the standards and test methods eligible for inclusion in the program, program specifications for those standards, and recommended contents specific to those standards.

Required under the 2017 FDA Reauthorization Act, the FDA’s pilot accreditation program would help to facilitate a more efficient review process for certain types of medical devices, allowing device manufacturers to bring new and innovated products to market more quickly.

Vintage TV Identified as Source of Broadband Outage
Residents of a small village in rural Wales can now breathe a sigh of relief after engineers identified a source of interference that resulted in the regular shutdown of the community’s broadband internet service.

According to a report posted last month to the CNN website, the village of Aberhosan was experiencing daily internet service outages every morning around 7 am for a period of 18 months. Repeated investigations by network operators turned up little that could explain the daily outages, and even replacing cables that serviced the area did not mitigate the problem.

Finally, Openreach, the company that runs the digital network in the United Kingdom, deployed their chief engineering team to investigate whether the source of the problem might be a single high-level impulse noise (SHINE), a form of electrical interference emitted from certain appliances that impact broadband signals. Using spectrum analyzers, engineers walked throughout the village to identify a potential source for the noise.

The investigation ultimately led to a vintage television in the home of a village resident, who habitually turned on the set every morning at 7 am, resulting in the shutdown of broadband services.

Openreach reports that the owner has “retired” the vintage television and that there have been no subsequent broadband outages in Aberhosan.

Retro TV turned off
FCC Grants ARRL Waiver Request for Fire Emergencies, Hurricanes
The U.S. Federal Communications Commission (FCC) has granted a request from the American Radio Relay League (ARRL) to temporarily waive symbol rate limits for amateur radio communications used during hurricane and wildfire relief efforts.

Symbol rates are the rates at which carrier waveform amplitude, frequency and/or phase is varied to facilitate the transmission of information. Under current FCC rules, symbol rates applicable to high frequency (HF) amateur radioteletype (RTTY/data transmissions are limited to 300 bauds for frequencies less than 28 MHz and 120 bauds in the range between 28-29.7 MHz.

The ARRL submitted a petition to the FCC in 2016 to remove the symbol rate limitations due to advances in modulation techniques. While a decision on that petition is still pending, the ARRL also sought an emergency waiver of the symbol rate limits for licensees supporting hurricane and wildfire relief efforts via HF using PACTOR 4 modems, which permit relatively high-speed data transmission rates.

The FCC approved the temporary waiver requested by the ARRL expressly for emergency relief communications using PACTOR 3 and PACTOR 4 emissions within the U.S. and its territories. The period of the waiver is limited to 60 days from the date of the FCC’s order, September 17, 2020.

FDA Issues Guidance on Recognition of Voluntary Consensus Standards
The U.S. Food and Drug Administration (FDA) has issued a guidance on how the agency addresses requests for recognition of a voluntary consensus standard for use in the assessment of medical devices.

Issued in mid-September, the guidance, “Recognition and Withdrawal of Voluntary Consensus Standards,” details the procedures the agency’s Center for Device and Radiological Health (CDRH) follows in evaluating potential consensus standards and sets forth the principles it uses to recognize a standard wholly, partially or not at all. The guidance also provides information on the reasons or rationale behind decisions to withdraw a consensus standard.

Voluntary consensus standards that have been “recognized” by the FDA have been evaluated and determined as appropriate for use by medical device manufacturers in demonstrating conformity with the FDA’s relevant requirements. Frequently, consensus standards recognized by the FDA can also be used to demonstrate conformity with requirements in other jurisdictions, such as the European Union’s Medical Device Regulation (MRD).

You Can’t Make This Stuff Up: 2020 Ig Nobel Prizes Announced
And now for a bright spot in our chaotic world…

The 30th First Annual (not a typo!) Ig Nobel Prize ceremony was held virtually last month. Not to be confused with the Nobel Prizes being announced this week in Stockholm, Sweden, the Ig Nobel Prizes are intended to “honor achievements that first make people laugh and then make them think.”

This year’s Ig Nobel Prize award winners include:

  • For physics, a team of researchers from Australia, Ukraine, France, Italy, Germany, the United Kingdom and South Africa for determining experimentally what happens to the shape of a living earthworm when the earthworm is vibrated at a high frequency;
  • For acoustics, researchers from Austria, Sweden, Japan, Switzerland and the U.S. for inducing a Chinese alligator to bellow in an airtight chamber filled with helium-enriched air;
  • For economics, researchers from the United Kingdom, Poland, France, Brazil, Chile, Columbia, Australia, Italy and Norway for their efforts to quantify the relationship between different countries’ national income inequality and their average amount of mouth-to-mouth kissing;
  • For psychology, Canadian and U.S. researchers for devising a method to identify narcissists by examining their eyebrows
  • And finally, for peace, researchers from India and Pakistan for having their diplomats ring each other’s doorbells in the middle of the night, and then run away before anyone had a chance to answer the door.
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