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bb254 started the topic Combination Product in the forum Regulatory Basics for Medical Devices 7 years, 8 months ago
Name a combination product which is currently on the market such as a drug releasing stent.
Specify the primary mode of action and department you believe that the device should be under(CDER, CBER, CDRH). Explain.
Based on your selection, layout the regulatory process which would need to be done for that medical device to be marketed.