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The FDA guidelines for 3D printing medical devices are refined and refined

Submitted by baitron on Tue, 12/27/2016 - 21:16

Recently, the US Food and Drug Administration (FDA) is studying the 3D printing technology in the medical industry application. FDA will provide more accurate guidance on 3D printing equipment by exploring management, research and resources.

For Americans, the FDA plays a big role in their daily lives. Whether it is through testing to find the right drugs, or in food packaging on the strict supervision, are FDA for citizens to make contributions. In recent years, FDA has become more and more concerned about the field, including 3D printing medical equipment.

Now, if medical equipment manufacturers want to 3D implant, 3D printing stent or other 3D print drugs into the medical market, it must first be submitted to the FDA for approval. In fact, there will always be part of the product is not approved. But perhaps not because of product quality, but because they have a certain novelty, in the past, the application of 3D printing equipment can not refer to the example, so the FDA will not be approved. m83513/03-d03n

To safeguard the interests of these 3D-print medical device manufacturers, the FDA decided to create a guide for 3D printing devices that would clearly define 3D print medical devices. In fact, as early as the beginning of this year, FDA has published a draft of this guide, and invited the public comments to improve and improve the guide. Subsequently, AdvaMed, Johnson & Johnson and Materialise and other companies put forward their ideas, FDA also adopted some of the views and modify. lqh6ppn101m43l

According to the FDA's latest video, the guide provides a brief overview of the importance of medical 3D printing, as well as the need for strict regulation of the production of such products by the private sector. At the same time, management, research and resources of these three are indispensable. Management refers to FDA's efforts to test new 3D print products for the healthcare industry, and as a result of the new guidelines being finalized and distributed to private companies, their next work will be relatively easy. The study refers to the FDA is trying to develop exciting new technologies, and 3D printing research laboratory to reach cooperation. As for the resources, it represents the FDA is currently the new guidelines are available to those who are looking for new 3D printing products company, to bring them the direction of development.