Inspection-Challenged FDA Defies Odds By Issuing Most Quality-Related Warning Letters Since 2017
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.
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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.
OMB Completes Review Of FDA’s Draft Harmonized Quality System Regulation
The White House Office of Management and Budget’s concluded action was “consistent with change,” which means modifications were made to the draft rule during its review.
FDA Extends On-Site Surveillance Inspections Freeze Another 2 Weeks Because Of Omicron
The US agency had previously decided to halt domestic inspections through at least 19 January because of the COVID-19 Omicron variant. But now that timeline has been lengthened.