3D printing medical devices: stakeholders weigh in on FDA’s discussion paper

RAPS

15 February 2022 - The US FDA has started thinking about how 3D printing of medical devices at the point of care would be regulated, and asked stakeholders to weigh in late last year.

While not a draft or final guidance, the discussion paper from December 2021 is a step toward exploring how FDA could oversee 3D printing of medical devices that fall under the purview of the Center for Devices and Radiological Health. 

The implementation of 3D printing could help health care facilities develop rapid personal care solutions for patients in need of medical devices and would also allow for the quick manufacturing of 3D printed devices near where the patient is being seen, FDA said.

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Michael Wonder

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Michael Wonder

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US , Regulation , Device , 3D printing