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US FDA Presents 3D Printing Scenarios To Spark Discussion, Lead To Future Guidance

The agency recently published a paper to spark discussions in the medtech industry on how to best regulate 3D printing of medical devices at points of care such a clinics and hospitals.

• Source: US Food and Drug Administration

The US Food and Drug Administration wants to hear from the medical device industry on how to regulate 3D-printed manufactured devices at point-of-care (POC) settings. Based on the feedback, it plans to develop a risk-based guidance that is not too burdensome.

It may sound like science fiction, but the future of medical devices as envisioned by many is a future where clinicians are able to 3D print devices at POC locations such as clinics and hospitals to provide personalized care. But that future also leaves regulators with a massive headache over how to oversee good manufacturing practices (GMP) of such devices

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