According to an Order issued by the FCC, the Emergency Broadband Benefit Program will offer consumers discounts of up to $50 per month on their broadband services, as well as a one-time $100 discount on the purchase of a laptop, desktop, or tablet computer from participating providers. The discounts are available until the $3.2 billion in federal funding has been exhausted, or six months after the U.S. Department of Health and Human Services (HHS) has declared an end to the COVID-19 pandemic.
Households can qualify for the discounts available under the Program through their use of existing assistance programs, such as SNAP, Medicaid, or Lifeline, or if a child in the household relies on a reduced-price school meals program. The discounts are also available to low-income households who suffered a large loss of income since February 29, 2020 due to job loss or furlough during the pandemic.
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 in each federal fiscal year between October 1, 2017, and March 31, 2018.
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 30-month evaluation period, the FDA accepted 282 submissions from four different accredited third parties, with 244 (86%) ultimately receiving final decisions from the FDA and with 22 decisions pending by the conclusion of the evaluation period. An additional 16 submissions to the FDA were withdrawn by the device manufacturer for unspecified reasons.
For those submissions receiving a final FDA decision, the average FDA review time for third-party submission was 32 calendar days or less, with an average of just 26 days in FY 2020. Average review times in the lowest 25th percentile of submissions was as low as 22 calendar days, while the maximum review time reached as long as 108 days.
Interestingly, the data suggests that the average review times for FDA decisions regarding third-party submissions may have benefited significantly from the extensive review conducted by third parties prior to their filing a 510(k) submission with the Agency. The average total time for third-party reviews conducted prior to an FDA 510(k) filling during the period ranged from 127 to 154 calendar days, with average review times in the lowest 25th percentile of between 49 and 66 days. However, the maximum total review time was as long as 836 days for submission data collected during FY 2020.
The EU Commission’s proposal to provide harmonized rules on the use of AI provides a legal framework that would both serve to promote the use of AI in future technologies while also addressing the risks associated with its use. The proposed regulation, which complements the EU’s General Data Protection Regulation (Regulation (EU) 2016/679) and its Law Enforcement Directive (Directive (EU) 2016/680), consists of three “core components,” as follows:
- Provide for a technology-neutral definition of AI systems that is future-proof, to the extent that it can cover techniques and approaches that are not known or developed.
- Avoid regulatory overreach by focusing on “high-risk” AI use cases, based on their intended purpose, the severity of potential harm, and the probability of its occurrence.
- Ensure that high-risk AI systems follow a set of specifically designed requirements, including: 1) the use of high-quality datasets; 2) establishing appropriate documentation to enhance traceability; 3) sharing of adequate information with the user; 4) the design and implementation of appropriate human oversight measures, and; 5) achieving the highest standards of robustness, safety, cybersecurity, and accuracy.
The Forfeiture Orders levy fines of $207,290 against IOU Acquisitions and $327,290 against Air-Tel LLC for offering wireless broadband-based GPS services that rely on satellite communications and wireless broadband. The companies were also found to have altered the settings of wireless equipment to operate the equipment outside of the frequency bands for which they were authorized.
The Forfeiture Orders followed an investigation by an FCC field agent at the companies’ joint facility in Denver, and the issuance of a Notice of Apparent Liability for Forfeiture in 2018.
According to an article posted on the website of the ARRL, the national association for amateur radio, recent changes to the FCC’s licensing system will mandate that examination applicants obtain an FCC Registration Number (FRN) in advance of their examination date. Examination applicants are required to provide their FRN on the Form 605 license application submitted to volunteer examiners.
The FCC has reportedly provided an instructional video that provides step-by-step instructions on how applicants can obtain an FRN through the FCC’s Commission Registration System (CORES).
The video is available at https://www.fcc.gov/rofrn.
In an updated advisory posted to its website, the FDA quotes recent studies that have shown the consumer electronics with high field strength magnets, such as some cell phone and smartwatch models, may cause certain implantable medical devices to accidentally switch into “magnet mode.” Magnet mode is a medical device safety feature that is typically activated during certain medical procedures and temporarily suspends normal device operations.
The FDA advises consumers with implantable medical devices to keep all consumer electronics at least six inches away from the implantable device. The agency also recommends that consumers not carry their electronic devices in a pocket over the medical device, and to use their home monitoring system (if available) to check the operational status of their medical device.
All new and existing medical devices must now conform with the requirements detailed in the EU’s Medical Device Regulation (2017/745, also known as the MDR).
Published in the Official Journal of the European Union in 2017, the MDR replaces the EU’s Medical Device Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC). The MDR originally provided medical device manufacturers three years to ensure that existing medical devices were compliant with the requirements under the new regulation. The EU Commission extended that period one additional year in April 2020, due to the impact of the COVID-19 pandemic on healthcare institutions, medical device developers, and regulatory authorities.
The MDR’s companion regulation on in vitro diagnostic medical devices (2017/746, known as the IVDR) provided in-vitro medical device manufacturers with a five-year transition period and is fully applicable to all in vitro devices as of May 2022.
The full application of the MDR and IVDR represents the culmination of a nearly 10-year process that began in 2012 when the European Commission first published initial proposals for the new regulations.