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  • merzkrashed replied to the topic Combination Product in the forum Project Management Process and Medical Device Development 7 years, 9 months ago

    An example of a combination product: Bone morphogenetic proteins (BMPs are a class of proteins) that induce bone formation. New technology in orthopedic repair combines BMPs with a carrier matrix to create a combination product that, when implanted in a bony defect, initiates bone formation (osteoinduction) and provides local containment and cell adhesion (osteoconduction).
    Example :FDA approved INFUSE bone graft, which contains a recombinant human bone morphogenetic protein (rhBMP-2),which consists of:Recombinant human bone morphogenetic protein (rhBMP-2); absorbable collagen sponge; sterile water. Class III
    Applications submitted:Separate applications submitted to CDRH and CDER: 510(k) (controller), NDA (patch)
    Manufacturer: Vyteris
    https://www.fda.gov/downloads/combinationproducts/meetingsconferencesworkshops/ucm116740.pdf