Action plan to regulate machine-learning software in 2021 revealed The US Food and Drug Administration wants manufacturers to specifically label AI-powered medical devices to help patients understand the technology, and to test them on real-world data to see how they perform in the wild beyond clinical environments.…
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Not even the Consumer Electronics Show can escape the effects of the ongoing government shutdown.Nearly a dozen government speakers, including Federal Communications Commission Chairman Ajit Pai and U.S. Secretary of Transportation Elaine Chao, will have to skip their speaking engagements at the annual tech convention this week in Las Vegas because of the shutdown, the conference’s organizers said.Eleven speakers from the federal government, including staffers from the Environmental Protection Agency, the Food and Drug Administration, the Federal Trade Commission and the Department of Homeland Security, will no longer be attending CES, where the tech world convenes each January to discuss industry developments and unveil their latest products.“Because of the government shutdown, some of our scheduled government speakers at CES 2019 have alerted us that they must cancel their travel to the show,” said Gary Shapiro, president and CEO of the Consumer Technology Association, which organizes CES, in a statement.“We urge attendees who planned to hear U.S. federal government speakers to check the sessions on the website to ensure those individuals are still speaking,” he added.Among the other speakers to cancel were Federal Trade Commission Chairman Rohit Chopra, FTC Commissioner Rebecca Slaughter, FCC Commissioner Brendan Carr, Food and Drug Administration associate director for digital health Bakul Patel and deputy director of the Office of Superfund Remediation and Technology at the EPA Barnes Johnson.
p When Bakul Patel started as a policy advisor in the US Food and Drug Administration in 2008, he could pretty much pinpoint when a product was going to land in front of the reviewers in his division.Back when medical devices were heavy on the hardware—your pacemakers and your IUDs—it would take manufacturers years to get them ready for regulatory approval.But as computer code took on more complex tasks, like spotting specious moles and quantifying blood flow, their duties began to accelerate.It got harder to match pace.For most regulators, an ever-changing algorithm is their worst nightmare.But Patel is one of those rare Washington bureaucrats who’s also a fervently optimistic futurist.
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