FDA’s New Guidance’s Deciding When to Submit a 510(k) for Device and Software Changes
September 21, 2018 - Online Event ON CAWebinar Compliance
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The U.S. FDA had published two New Guidance Documents, “Deciding When to Submit a 510(k) for a Change to an Existing Device”, 1) on the device itself, and 2) on device software. These documents attempt to provide companies tools to perform meaningful, results driven 510(k) / change analysis activities. This is part of a growing push by the Agency to strengthen the 510(k) process. The addition of simple tools will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when one or several changes may require a new 510(k) submission.
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