In May of this year, the US Food and Drug Administration (FDA) issued a draft guidance on 3D printed medical devices. The FDA publicly solicited opinions before August 8, and the FDA will then formulate a more fair and comprehensive rule based on these feedbacks. . The 3D printed medical device guidance draft issued by the FDA in May is a long-awaited one. It is known as an important moment in the history of 3D printing medicine. But now, 3D printed medical devices and drugs need to be processed longer before more fair and comprehensive rules come out. This process is very painful for manufacturers, but according to FDA announcements, it is generally accepted that 3D printed devices and drugs are not safe enough before they have formal guidelines. With the introduction of new guidelines, people will be able to develop and market drugs for 3D printing devices through a simpler process. It is understood that the draft guidelines for 3D printed medical devices are divided into two categories: design and manufacturing, and equipment testing. “We try to describe the known basic materials, specifications, biological formats, etc. with professional words, and then we must guide the various departments to supervise the 3D printing equipment and drugs. This has a good development of additive manufacturing. The role is to let the manufacturer know what to do and what it needs,†said James Coburn, senior research engineer at the FDA Radiation Health Center. Piezoelectric System Scaler,Dental Piezo Scaler,Dental Piezosurgery Scaler,Piezo System Scaler Rolence Enterprise Inc. , https://www.rolencedent.com
FDA will announce 3D printed medical guidance program in August
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