US FDA proposes to streamline de novo medical device review pathway
This article was originally published in Clinica
The US Food and Drug Administration is seeking feedback on proposals to streamline the "cumbersome" de novo review programme that is it uses for certain innovative, low- to moderate-risk devices that cannot be cleared by the pre-market notification, or 510(k), process. The proposals are expected to trim off up to 90 days from the de novo programme.
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