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Definition of a Combination Product

The term combination product includes: 

          -  A product comprised of two or more regulated components, i.e., drug/device, biological/device, drug/biological, or 
             drug/device/biological, that are physically, chemically, or otherwise combined or mixed and produced as a single
             entity;

          -  Two or more separate products packaged together in a single package or as a unit and comprised of drug and device
             products, device and biological products, or biological and drug products;

          -  A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling
             is intended for use only with an approved individually specified drug, device, or biological product where both are
             required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling
             of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength,
             route of administration, or significant change in dose; or

          -  Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is
             for use only with another individually specified investigational drug, device, or biological product where both are
             required to achieve the intended use, indication, or effect.


DEVICE JURISDICTION 

Last Updated ( Wednesday, 16 March 2016 )
 
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