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Table 1 FDAs definition of three potential scenarios for 3D printing within HCFs [10]. Please note that the prose is copied directly from the Discussion Paper. However, footnotes from the FDA are not included. Please see the FDA website to download the full document

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

  Scenario 1: Healthcare facility using MDPS Scenario 2: Traditional Manufacturer Co-location Scenario 3: HCF assumes all manufacturer responsibilities
Entity designing/ developing the device Traditional Manufacturer Traditional Manufacturer Healthcare Facility
Entity using the 3D printing system to produce devices Healthcare Facility Traditional Manufacturer, including any potential Contract Manufacturer Healthcare Facility
Entity responsible for complying with applicable regulatory requirements Traditional Manufacturer Traditional Manufacturer, including any potential Contract Manufacturer Healthcare Facility