FDA Issues Long-Awaited 3D Printing Guidance for Medical Devices

Published 05/16/2016

The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), which is more commonly known as 3D printing.

In March, FDA approved the first-ever 3D printed drug, Aprecia's epilepsy drug SPRITAM, which relies on 3D printing technology to rapidly disintegrate in a patient's mouth, making it easier to swallow. For biologics, researchers are looking into 3D printing as a means of manufacturing cell and tissue products.

However, for medical devices, 3D printing technology is much farther along. So far, FDA has cleared more than 85 applications for 3D printed devices, though none have been for high-risk devices requiring premarket approval.

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