FDA’s FY 2023 Proposed Budget Asks For Millions To Curb Device Shortages, Bolster Cybersecurity, And More
The US FDA’s medical devices program would get a funding boost of more than 9% over the current fiscal year if the agency’s latest budget request is granted as-is by Congress.
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Digital Health: FDA’s Shuren Predicts ‘Critical Regulatory Hurdles’ If Congress Doesn’t Update Reg Frameworks
US FDA device center director Jeff Shuren is strongly urging lawmakers to come up with modern digital health regulatory frameworks and more strongly tackle cybersecurity issues.
US FDA data shared with Medtech Insight show that the number of quality-related warning letters sent to device manufacturers in calendar year 2021 ticked up 33% from 2020. Last year’s enforcement missives were also the most handed out by the agency in four years.
The ECRI report of the top threats to the healthcare industry in 2022 has cybersecurity leading the list. COVID-19-related issues such as supply chain shortages and lack of emergency stockpiles are also on the list.