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djr32 started the topic Combination Product in the forum Project Management Process and Medical Device Development 8 years, 2 months ago
A while ago we studied about combination device, which may include two or more separate products packaged together or includes products sold separately but intended for use with another type of product.
Find a combination device and explain what it does. Is it class I, II, or III? Why? What steps would it have to take to be approved by the FDA?