US approvals of high-risk medical devices are way down

Last year the FDA kept up a scorching pace of medical device approvals in tandem with rushing Covid-19 diagnostics, and other devices necessary to aid with the pandemic, to market via emergency authorisations.

Now it seems that burnout might have hit the agency. During the first six months of 2021 the FDA awarded just 12 first-time premarket approvals and one humanitarian device exemption. If this rate is maintained throughout the second half this year will see the fewest high-risk devices reach the US market since 2013.