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Medical Devices with 3D Printing Facility

The US Food and Drug Administration (FDA) began considering how 3D Printing of medical devices at the point of care (PoC) would be regulated late last year, and invited stakeholders to comment. The December 2021 discussion paper, while not a draught or final guidance, is a step toward determining how FDA could monitor of medical devices that fall within the Center for Devices and Radiological Health’s jurisdiction (CDRH).

According to the FDA, 3D Printing could assist healthcare facilities (HCF) in developing speedy personal care solutions for patients in need of medical devices, as well as allowing for the quick fabrication of 3D-printed products near where the patient is being treated. The FDA acknowledges that at the point of care helps to develop novel device designs, clinical solutions, and improved approaches to unusual and complex patients.

As 3D Printing opens up new prospects for product development in the PoC, FDA plans to continue supporting innovation while maintaining reasonable assurance of device safety and effectiveness. HCFs became more interested in employing at PoC to alleviate shortages of medical devices and some personal protective equipment during the COVID-19 pandemic, according to FDA. They did point out, however, that 3D Printing might be employed in non-emergency scenarios.

Because 3D Printing is a new technology, FDA wants to make sure that any solution it implements is long-lasting and based on solid research, rational clinical guidelines, and an appropriate regulatory strategy that balances innovation and regulatory control. A list of 16 questions was included in the discussion paper for stakeholders to examine across a variety of concerns at PoC.

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