FDA Final Guidance: No Corrections And Removals Reports For Device Enhancements
This article was originally published in The Silver Sheet
Online-Only Content >>> CDRH clarifies that Part 806 recall reports are not necessary for actual device enhancements that do not qualify as a correction or removal.
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The draft guidance is an attempt by FDA to reassure companies that they can make an enhancement to a marketed device without worrying that the action will be perceived as a recall. But the effort appears to have increased, rather than alleviated, industry anxieties.
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