Dear Forum,
I am struggling with the exact definition of scientific disciplinces in the context of the FDA Special 510(k) guidance.
The guidance talks about three scientific disciplines.
So lets assume you evaluate a change that triggers basic safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) verification testing.
Would you evaluate both subject areas as ONE or as TWO scientific disciplines in the context of a Special 510(k) submission?
Kind regards,
Michael
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Michael Hottner
Köln
Germany
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