Dec 22, 2016 | By Benedict

Regulation, Research, and Resource. According to a new video, those three Rs are the ways in which the U.S. Food and Drug Administration (FDA) is concerned with 3D printing in the medical industry.

Whether by testing potentially life-saving drugs or making sure that food packets are labelled correctly, the U.S. Food and Drug Administration, usually referred to as the FDA, plays a huge role in the heath of America’s citizens. In recent years, however, its purview has widened to include new areas of concern such as 3D printed medical devices.

These days, if a medical device manufacturer wishes to introduce a 3D printed implant, stent, or other even a 3D printed drug onto the medical market, it must first submit its creation to the FDA, which will then decide whether to approve the item for medical use. Many of these items are granted FDA approval, but many are not, and this is partially down to the relative newness of 3D printing: since there are few precedents for 3D printed medical devices, companies are sometimes unsure what exactly the FDA is looking for when it comes down to approving or rejecting a product.

The FDA is heavily involved in 3D bioprinting research

In order to make life easier for medical device companies, the FDA is currently in the process of developing guidance for 3D printed devices that will lay out clear specifications for what is and isn’t acceptable when making 3D printed products for medical use. The organization posted a draft version of this guidance in early 2016, before inviting comments from the public in order to refine and improve the documents. Eventually, companies like AdvaMed, Johnson & Johnson, and Materialise contributed their thoughts, and the FDA is currently working on a finalized version of the papers.

In a new video posted by the FDA, the organization gives a brief introduction to its role in the world of medical 3D printing, which actually goes beyond regulating products being made by private companies. According to the video, which is scored by intense dubstep music, the FDA’s role in medical 3D printing can be summarized in terms of “three Rs”: Regulate, Research, and Resource.

FDA resources help companies develop 3D printed medical devices

The first of the three Rs, Regulate, refers to the FDA’s efforts to test new 3D printed products for the medical industry—a job that should become much easier once the new guidance is finalized and circulated to private companies. The second, Research, refers to the organization’s collaborations with research labs that are trying to develop exciting new technologies. These technologies include new 3D bioprinting processes, which could someday be used to 3D print transplantable human organs. Resource, the final R, pertains to the guidance documents that the FDA provides (and will provide) to companies that are looking to make new 3D printed products.

The FDA has, as of today, cleared more than 85 3D printed devices, mostly through the 510(k) or emergency use pathways.

FDA regulations are designed to ensure that all 3D printed medical devices are safe

Watch the full video below.



Posted in 3D Printing Application



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