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Anyone had any direct experience, good or bad, with the FDA Office of Antimicrobial Products (under CDER) in regard to their requirements for device-related applications of antimicrobial surface coatings on devices?
So far, I haven't managed to call them when anyone was home. Maybe my timing is just bad, in regard to the move to the new White Oak office complex.
The application in question is not drug elution, and the surface coating substance is not pharma per normal definitions. We're purchasing the material from a well-regulatorily-managed supplier. Their support in regard to EPA FIFRA and prior successful FDA 510(k) experience has been exemplary. But, naturally we need to establish our own FDA relationship. This is my first experience with OAP.
I wish they were in the office more often.
So far, I haven't managed to call them when anyone was home. Maybe my timing is just bad, in regard to the move to the new White Oak office complex.
The application in question is not drug elution, and the surface coating substance is not pharma per normal definitions. We're purchasing the material from a well-regulatorily-managed supplier. Their support in regard to EPA FIFRA and prior successful FDA 510(k) experience has been exemplary. But, naturally we need to establish our own FDA relationship. This is my first experience with OAP.
I wish they were in the office more often.