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Speedier classification of low-risk, innovative devices in sight in US

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration has issued revised draft guidance on its de novo process that aims to speed the reclassification of new types of devices that present a relatively low-risk and for which no predicates are available1,2. 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.

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