US FDA proposes to speed up classification of certain low-risk, innovative devices
This article was originally published in Clinica
Executive Summary
The US FDA has issued revised draft guidance on its de novo process that aims to speed the reclassification of new types of devices that present a relatively low isk and for which no predicates are available. The updated guidance, when finalized, would give companies the choice of not submitting a pre-market notification, or 510(k) submission, before the start of the reclassification process.