US Regulatory Roundup, October 2021: Medtronic And Stryker Talk Recalls; Spotlight On Breakthrough Devices; And More

Medtech regulatory professionals talked about medical device recalls at a US FDA meeting, while experts said they’re concerned about the future of the soon-to-be-withdrawn MCIT rule that would’ve given four years of Medicare coverage to breakthrough devices. These and other stories topped our list of most-read articles last month.

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Medical device safety and product recalls were hot topics in October, with news of the US Food and Drug Administration reclassifying surgical staplers from low-risk class I to moderate-risk class II being the most-read story for Medtech Insight readers.

The FDA proposed reclassifying the staplers in 2019 after reviewing reports of more than 40,000 adverse events related to the...

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