Medical devices combination biologic/device products

A major challenge for both developers and regulators of biologic-device combination products is the potential need to reconsider how to measure certain key parameters typically associated with the preclinical assessment of standalone medical devices and biologies with the goal toward extrapolation of the information to humans. 

Under current federal law, every medical product is classifiable as a drug, device, biological product (a biologic ), or combination product (i.e., a combination device/drug, device/biologic, etc.). The classification of the product determines the particular processes of review and approval the FDA may employ in determining the safety and efficacy of the product for human use. 

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