An article posted to the website of JD Supra summarizes a recent FDA investigation of the facility of a California-based medical device manufacturer (Q’Apel Medical, Inc.), during which inspectors identified several concerns regarding a previously cleared medical device. The issues included design modifications and misbranding concerns, each of which required the company to obtain a new 510(k) notification to reflect these changes.
Under FDA regulations, manufacturers seeking to make changes to medical devices originally cleared under the 510(k) process must conduct a risk-based assessment to determine whether the proposed changes alter the device sufficiently to affect the safety or efficacy of the device or lead to a significant change in its intended use. If so, the manufacturer is required to make a new FDA 510(k) submission.
According to a press release issued by the Office of FCC Chair Brendan Carr, some of the entities on the Covered List may still be operating within the U.S., in violation of the prohibitions under FCC regulations. The FCC has already sent Letters of Inquiry to each of the listed entities to determine what, if any, further actions are required.
The FCC’s investigation will be conducted by the Commission’s new Council on National Security.
The FCC’s Covered List includes those companies whose equipment or services “pose unacceptable risks to America’s National Security.” The List was originally created in early 2021 and currently includes 11 separate entities.
According to a press release issued by the Commission, the data shows that the majority (70%) of EU consumers believe that retailers and service providers respect consumer rights, while 61% of consumers trust public organizations to protect those rights.
However, other results complicate those top-level findings. For example, more than 60% of online shoppers say they are more likely to experience problems with their purchases than those who shop offline. Further, 93% of online shoppers worry over online targeted advertising, including the collection of personal data and excessive advertising, while 45% have encountered online scams and other unfair practices, including fake reviews and misleading discounts.
And, in the uncertain global economy, 38% of consumers expressed concerns about their ability to pay their bills, as well as 35% who worry about affording their preferred foods.
The latest Biennial Consumer Conditions Scorecard is based primarily on data from the Commission’s Consumer Conditions Survey conducted in November 2024.

Then, the caller claims to need money for an emergency purpose, such as for bail in the case of an arrest and advising the call recipient to give cash to a “bail bondsman” who will come to the target’s home to collect the money.
Leveraging the latest technology, some callers even use artificial intelligence (AI) technology to clone the voice of the real relative being impersonated by the caller.
The U.S. Department of Justice has reportedly indicted 25 individual Canadian nationals for participating in the fraudulent robocall scheme for defrauding elderly individuals in more than 40 U.S. states.