Table 1 Proposed FDA Framework for Medical PoC 3D Printing

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]