Table 1:

FDA-approval process for bone grafts, describes 510K, IDE/PMA, and HCTP approval processes.

FDA-approval Processes:	Process of Approval:
510K	The 510K process is a premarket submission is that the device is at least as safe and effective, that is, substantially equivalent, to a legally marketed device [15].
IDE/PMA	An IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. This data will then be used to support the Premarket Approval [16].
HCT/P	HCT/P’s are regulated by the Center for Devices and Radiological Health as medical devices and/or are regulated by the Center for Biologics Evaluation and Research [17]. Whether products are regulated by one or both of these agencies depends on the product wanting to be marketed. No premarket approval is needed through the FDA.
RMAT	RMAT’s must be made with an existing or new Investigational New Drug (IND) application. This designation includes certain human gene therapies and xenogeneic cell products[18].