Medical Device Changes, the 510(k) and FDA's Two Guidance Documents on Device and/or Software Changes
March 24, 2020 - FL USWCS Consulting Inc
subscribe@worldcomplianceseminars.com
Phone:3472825400
This webinar will discuss both US FDA Guidance Documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device”; and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device“; both dated November 16, 2017. It will examine the broad range of issues to be considered by a company when reviewing 1) a series of minor changes or 2) one major change to an existing product having an existing 510(k), for the need for a new 510(k).
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