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Hello All,
At what point does FDA's substantial equivalence determination become extra-procedural use of the process to effectively give FDA rescission authority, by eliminating clams from cleared devices the Agency no longer wants to clear in new devices? For example, a predicate device, an antimicrobial gel, was cleared with the claim as an effective antimicrobial barrier. The new device wants to get that same claim, but now must accomplish more and different testing than the predicate, and there must be heavy labeling caveats on the claim concerning clinical relevance. The predicate device did not accomplish the extensive testing nor required to have these labeling caveats.
At what point is this "comparison" now independent demonstration?
Your thoughts, approaches, and guidance are appreciated.