Bone graft regulation classification

FDA regulation category	Product
Human cells, tissues, and cellular and tissue-based products (HCT/Ps)	Allograft, demineralized bone matrices (DBM), cell-based matrices
510(k)	DBM mixed with other materials (eg, polymer), synthetics
Class III drug-device combination	Bone morphogenic protein, peptides, platelet-derived growth factor

Reference:

Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff. U.S. Department of Health and Human Services. Available at: https://www.fda.gov/media/80384/download (Accessed on February 16, 2022).

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