Deciding When to Submit a
510(k) for a Software Change to an Existing Device ______________________________________________________________________________
Guidance for Industry and
Food and Drug Administration Staff
Document issued on October 25
Deciding When to Submit a 510(k) for
a Change to an Existing Device
Guidance for Industry and
Food and Drug Administration Staff
Document issued on October 25, 2017.
The draft of this document was issued on August 8, 2016.
This document super
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