The U.S. Food and Drug Administration (FDA) has issued a public call for comment on a future-proof regulatory framework it’s designing to ensure the quality of 3D printed medical devices.
Published in the form of a discussion paper, the FDA document not only outlines how point of care 3D printing is governed, but identifies challenges to its end-use and offers a revised potential ruleset. Rather than serving as guidance, the FDA says these suggestions are meant to “pose questions,” thus it’s now requesting feedback from the medical 3D printing industry that will help inform future regulation.
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