According to a press release, Acting FCC Chairperson Jessica Rosenworcel proposed the additions to help expand the agency’s efforts to help foster the development and integration of 5G network technologies and open radio access networks (RANs). If adopted by the Commission, Boston and Raleigh would join New York City and Salt Lake City under the agency’s Innovations Zones initiative, which seeks to expand the geographic areas where those holding experimental program licenses can conduct research and testing of these technologies.
The Boston Innovation Zone would be centered at Northeastern University, while the Raleigh Innovation Zone would be based on collaborations with North Carolina State University.
Rosenworcel’s proposed changes to the Innovation Zones initiative would also expand the New York City Innovation Zone to include three Columbia University and City College of New York campus areas.
The Commission will require that all reports and applications administered by its International Bureau be filed electronically through its International Bureau Filing System (IBFS). The expanded requirements will apply to Section 325(c) Applications, Applications for International High Frequency Broadcast (IHF) Stations, and Dominant Carrier Section 63.10(c) Quarterly Reports.
The FCC’s Order also removes duplicate paper filing requirements for satellite cost-recovery International Telecommunications Union (ITU) declarations.
The Commission says that the decision to expand its mandatory electronic filing requirements is part of its overall efforts to streamline the filing process, reduce the costs for applicants, carriers, and Commission staff, and increase the transparency of this information.
The report, “Recommendations for Tackling Fires Caused by Lithium Batteries in WEEE,” compiles the findings of an industry survey conducted in 2019 by a consortium of EU-level associations of WEEE manufacturers and recyclers.
Part 2 of the report provides a compilation of the findings of that survey, listing nearly 30 different recommendations and good practices for reducing the risk of fires associated with WEEE batteries and addressing issues related to design, collection, and logistics, as well as policy matters.
The report makes clear that there is no “magic formula that will reduce to zero the risk of fires caused by WEEE containing batteries.”
The Commission of the European Union (EU) has updated its list of harmonized standards applicable to in vitro medical devices to reflect the latest available technical and scientific information.
According to Commission Implementing Decision (EU) 2021/1195, two new standards can now be used to demonstrate compliance with applicable requirements of the EU’s In Vitro Diagnostic Device Regulation, (EU) 2017/745. These are:
- EN ISO 11737-2:2020, “Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)”
- EN ISO 25424:2019, “Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)”
In addition, the Commission’s Implementing Decision designated amendments to current harmonized standards, as follows:
- EN ISO 11135:2014/A1:2019, amendment to “Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)”
- EN ISO 11137-1:2015/A2:2019, amendment to “Sterilization of healthcare products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1: 2006, including Amd 1: 2013)”
Under Commission rules, compliance with an EU harmonized standard confers a presumption of conformity with the corresponding essential requirements in EU harmonization legislation once the standard has been published in the Official Journal of the European Union.
According to Commission Implementing Decision (EU) 2021/1195, two new standards can now be used to demonstrate compliance with applicable requirements of the EU’s In Vitro Diagnostic Device Regulation, (EU) 2017/745. These are:
- EN ISO 11737-2:2020, “Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)”
- EN ISO 25424:2019, “Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)”
- EN ISO 11135:2014/A1:2019, amendment to “Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)”
- EN ISO 11137-1:2015/A2:2019, amendment to “Sterilization of healthcare products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1: 2006, including Amd 1: 2013)”