FDA Adds To 510(k) Exemptions List, Responding To Lost, Now Found, Public Comments
This article was originally published in The Gray Sheet
FDA updated its guidance on exempting certain unclassified and class II/class I devices from 510(k) requirements by adding eight additional products to the earlier list of 120 exempted. The codes were recommended in public comments that FDA neglected to review prior to publishing its original July 1 guidance.
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