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Table 2 Summary of A-E from the Potential 3D Printing Scenarios proposed by the FDA in 2019

From: The impact of regulation, reimbursement, and research on the value of 3D printing and other 3D procedures in medicine

A: Minimal risk 3D printing at HCF
B: Device designed by manufacturer using validated process with turn-key system
C: Device designed by manufacturer using validated process that requires additional capabilities within the HCF
D: Manufacturer is co-located at a HCF
E: HCFP becomes a manufacturer