Wednesday, September 27, 2023

Short Takes – 9-27-23

Senate grabs wheel from House in bid to avoid shutdown. article. Pull quote: “They [un-named Senators] believe that if he saves the country from going through an unpopular government shutdown, he’ll have enough political capital to beat back any move by conservative critics such as Rep. Matt Gaetz (R-Fla.) to push through a motion to kick him out of the top leadership job.” Political calculus or wishful thinking?

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability. Federal Register FDA notice of availability. Summary: “The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” As more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, ensuring medical device safety and effectiveness includes adequate medical device cybersecurity, as well as its security as part of the larger system. This final guidance supersedes the final guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” issued October 2, 2014.”

McCarthy told conference he won’t allow vote on Senate stopgap: GOP lawmakers. article. Pull quote: “Good told reporters that McCarthy’s stopgap measure would keep the government open for 30 days, decrease spending to a top-line level of $1.471 trillion for that duration and include border security provisions. Good also noted that McCarthy wants to pass the stopgap “in conjunction with continuing to move our spending bills,” which has been a key demand among conservatives.”

House GOP agriculture spending bill on thin ice. article. Pull quote: “The House GOP’s bill to fund the Department of Agriculture, rural development and the Food and Drug Administration (FDA) is on thin ice after a handful of moderate Republicans said they are opposed to the legislation because of a provision that would limit access to an abortion pill.”

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