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Table 1 Proposed FDA Framework for Medical PoC 3D Printing

From: Interpretation of regulatory factors for 3D printing at hospitals and medical centers, or at the point of care

Scenario Additional Details and Considerations
A healthcare facility prints and uses 3D-printed devices in a way that presents minimal risk in terms of patient safety and ability to print • Should employ monitoring and risk mitigations strategies
• Should leverage existing standards, certifications
• Not intended for implants, life-supporting / life‐ sustaining devices or devices that present a serious health risk to patients
A device is designed by manufacturer to be printed by the healthcare facility where the post-processing steps are automatic or self‐contained • Uses a validated process that has been evaluated by FDA
• Device use should be consistent with cleared indications and manufacturer instructions for use
A device is designed by manufacturer to be printed by the healthcare facility where there is more complex manufacturing and post-printing processes • The healthcare facility would have to have appropriately trained personnel and proper equipment
• May require labeling, training, instructions for calibration, or testing on-site in order to facilitate appropriate 3D printing by the healthcare facility
A manufacturer or contract manufacturer is co- located at the healthcare facility • The healthcare facility doesn’t intend to set up and manage their own 3D facility or the devices are not minimal risk
• The healthcare facility is performed by a traditional manufacturer, contract manufacturer, or other 3rd party using their own equipment and personnel
A healthcare facility chooses to become a manufacturer (develop, test, print) and the devices are not minimal risk • The healthcare facility desires to design and control their own 3D printing operations and the devices are not minimal risk
• The healthcare facility is responsible for development/design, testing, and printing
• The healthcare facility is responsible for all regulatory requirements
Adapted from the presentation “3D Printing Medical Devices at Point of Care” [9]