FDA issues guidance for 3-D-printed medical devices

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Additive manufacturing, more commonly known as 3-D printing, is a technology that some say will revolutionize manufacturing. Objects are built by adding successive layers of a material according to designs from computer-aided design drawings or MRIs.

Within the medical field, orthopedic implants, surgical instruments and various prosthetics are a few of the applications for this potentially game-changing process. The U.S. Food and Drug Administration (FDA) had already approved 85 3-D-printed medical devices by the start of 2016.

On May 10, the FDA issued a draft guidance on 3-D printing of medical devices, covering both design and testing considerations. The document is an initial step in the FDA’s process for regulating approvals. The guidelines in the document help those using or potentially using devices produced by 3-D printing understand the regulatory concerns of the FDA.