FDA proposes exempting 337 Class II devices from 510(k) requirements

By Stewart Eisenhart, Emergo Group

US medical device regulators at the Food and Drug Administration (FDA) have proposed exempting hundreds of moderate-risk devices from 510(k) premarket notification requirements as the agency begins implementing components of the 21st Century Cures Act passed in late 2016.

Get the full story here at the Emergo Group’s blog.

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