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  • psm34 replied to the topic Combination Product in the forum Project Management Process and Medical Device Development 7 years, 1 month ago

    Catheter with antimicrobial coating is another example of a combination product. This allows the catheter to function as it is intended but prevents catheter-associated urinary tract infections (CAUTI). This allows the user to use a catheter with the same function as one with no coating on it, but with less risk of infection. This is submitted to the FDA as a class II device.