FDA to Issue More Guidance on 3D Printing

Regulatory NewsRegulatory News | 21 December 2016 |  By 

As manufacturers use 3D printing to create devices matched to a patient’s anatomy and devices with complex internal structures, the US Food and Drug Administration (FDA) is working with universities, researchers and industry to further understand these products and issue more guidance.

According to a video (The 3Rs of 3D printing: FDA’s Role) from FDA posted Wednesday, Lt. James Coburn, senior research engineer at FDA, says, “We’re a long way off from having a 3D printed kidney or heart” but the agency is working to better understand the technology to protect the safety of patients and will issue future guidance on the topic.

In March, FDA approved the first 3D printed drug, Aprecia's epilepsy drug Spritam (levetiracetam). For biologics, researchers are considering 3D printing as a way to better manufacture cell and tissue products.

However, for medical devices, 3D printing technology is much farther along. FDA has cleared more than 85 3D-printed devices, most of them via the 510(k) or emergency use pathways. A couple of success stories highlighted by FDA include a hospital in Michigan that implanted a 3D printed device into a 3-month-old boy with a rare bronchial condition and saved his life. And a man who had 75% of his skull replaced with a 3-D printed implant.

In May, FDA also released new draft guidance to provide manufacturers with the agency's initial thinking about the technical considerations for manufacturing 3D printed devices, as well as its thoughts on characterizing and validating such devices.

The Advanced Medical Technology Association (AdvaMed) and others submitted general comments to FDA on the draft, with AdvaMed looking to separate patient-specific devices into a companion guidance and calling for clarity on regulatory expectations for point-of-care 3D printing and enhancements to cross-center collaborations at FDA.

3D Printing of Medical Devices


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