The Dos and Don’ts on 3D Medical Devices According to the FDA

3D Patient-Specific Limbs Photo Credit: 3D Printing Industry

As we all know, the U.S. Food and Drug Administration (FDA) is very strict and demanding when it comes to approving or denying new drugs and medical devices. When it comes to devices made using 3D printing technology, this is no exception.

3D printing of medical devices is currently one of the most rapidly expanding medical applications in the market. This technology creates three-dimensional objects with raw materials. According to the FDA, “medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics. As of December 2015, the FDA has cleared more than 85 3D-printed medical devices??? (FDA, 2016). Some medical uses this technology could potentially have include tissue fabrication, customized prosthetics, implants, anatomical models, and different types of pharmaceutical research.

Even though this new technology seems to be promising, we cannot forget that when the FDA is involved it is not all rainbows and sunshine, and the safety and well-being of the community come first. This year, they created draft guidance on the Technical Considerations for Additive Manufactured Devices for manufacturers that produce these types of 3D devices. The two areas this guide is mainly focused on are design and manufacturing, and device testing considerations.

Click here to read the full article.

Click here to read the entire PDF on the FDA’s draft guidance.

Click here to watch a video from ENERGY.GOV that shows the process of 3D printing