In a Report and Order, the Commission has listed four new standards that can be used by FCC-recognized accredited laboratories to evaluate equipment for conformity with FCC requirements.
The FCC’s Report and Order also includes a number of changes to currently referenced standards, mostly addressing obsolete references. The complete list of the additions and changes is in Appendix A of the Report and Order.
Published on the FDA’s website, the FAQs address a range of issues critical to achieving compliance with FDA requirements regarding cybersecurity that apply to medical device premarket submissions filed on or after March 29, 2023. Among other issues, the FAQs clarify the definition of a cyber device, identifies the parties and the types of premarket submissions which are subject to the new requirements, and details resources available to device manufacturers to aid in their efforts to achieve compliance.
Although cybersecurity requirements are now applicable to medical device premarket submissions, the FDA says that it will provide a six-month grace period for manufacturers, and will not issue “refuse to accept” (RTA) decisions for premarket submissions filed before October 1, 2023. Instead, until that date, the agency will work collaboratively with those making premarket submissions as part of its deficiency review process.
Regulation (EU) 2023/607 extends the validity date of certificates issued between May 25, 2017 and May 26, 2021 under the EU’s original directives on medical devices (90/385/EEC) and in vitro diagnostic medical devices (98/79/EC). For class III and certain class IIb devices, the new transition date by which a device manufacturer must demonstrate compliance with the MDR or IVDR is now December 31, 2027. The new transition date for all other class IIb devices and class IIa and class I devices is now December 31, 2028.
In addition, medical devices brought to market under the legacy directives during the original transition period based on a declaration of conformity but that now require notified body review under the MDR or IVDR may remain on the market until December 31, 2028.
Robert Metcalfe, who along with the late David Boggs developed a groundbreaking standard for connecting computers, was named the recipient of the 2022 Association for Computing Machinery (ACM) A.M. Turing Award. Metcalfe now joins other tech luminaries, including Sir Tim Berners-Lee (the World Wide Web) and Edwin Catmull (3D computer graphics) who have made lasting and technically important contributions in the computer science field.
Working at Xerox’s Palo Alto Research Center (PARC) in the early 1970s, Metcalfe was tasked with designing a network to connect the company’s newly developed personal computer that would allow connected computers to share information with each other. His work was detailed in an article, “Ethernet: Distributed Packet Switching for Local Computer Networks,” co-written with Boggs and published in 1976 in the ACM publication Communications of the ACM.
The Turing Award is named after Alan Turing who was instrumental in the development of modern theoretical computer science in the early 1900s. The award comes with a $1 million prize funded by Google.
Detailed in a Report and Order and Further Notice of Proposed Rulemaking, the new regulations will require mobile service providers to block certain robotext messages that originate from phone numbers that are unlikely to transmit text messages. Such numbers would include invalid, unallocated, or unused numbers, as well as numbers for which the designated subscriber has self-identified as never sending text messages. The Report and Order also requires mobile wireless services providers to establish a point of contact for text senders that they can use to enquire about blocked texts.
The FCC estimates that text messaging scams have increased more than 500% during recent years, rising from around 3300 in 2015 to nearly 19,000 in 2022. The growing risk to consumers from text messaging scams is reportedly the basis for the Commission’s decision to implement text-specific regulations.
In its most recent actions, the Bureau has proposed a penalty of over $2.3 million against a couple for operating a longstanding, unauthorized radio station, in Queens, NY. According to a Notice of Apparent Liability for Forfeiture, the couple’s pirate radio station, Radio Impacto 2, started operations as far back as 2008, generating complaints to the FCC as early as 2013.
Separately, the Enforcement Bureau has proposed an $80,000 penalty against a man who allegedly has been operating a pirate radio station in La Grande, Oregon since at least 2018.