Skip to main content

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