From 3D Print’s Sarah Saunders: It’s always exciting when 3D printing can play a role in making someone’s life better, and one of the very visible ways it does this is through the medical field, like with this 3D printed ankle fusion system, or this 3D printed titanium digital fusion implant. But you can’t get anywhere with some of these innovations without the all-important clearance from the Food and Drug Administration (FDA). As manufacturers continue to utilize 3D printing in order to create devices with complex internal structures that are better matched to patients’ anatomy, the FDA is working with universities, researchers, and industry to continue learning more about these products, so they can better issue guidance on the continuing medical creations. The organization is now issuing further guidance on 3D printing.
This comes only a few months after the FDA released new draft guidance for those pursuing medical 3D printing. The agency provided manufacturers with their initial thoughts about the many technical considerations in manufacturing 3D printed medical devices, and on characterizing and validating those types of devices. It also offered testing recommendations. However, the guidance doesn’t apply to the more complex 3D printing and bioprinting processes, like those involving cells and human tissues. The Advanced Medical Technology Association (AdvaMed), and others, submitted their general comments to the FDA on this guidance, some of which include calling for clarity on regulatory expectations for point-of-care 3D printing.
AdvaMed also wanted to separate patient-specific devices into a companion guidance.
There are all kinds of things to consider when 3D printing for the medical sector, including if the material is safe to be used around food and beverages. The first 3D printed drug received FDA approval last year. Aprecia Pharmaceuticals’ dissolvable epilepsy drug Spritam (levetiracetam) was created using their 3D printing method, ZipDose, where dosages of up to 1,000 mg can be easily administered. So just how does the FDA use 3D printing in order to protect and promote public health? By using the three Rs of 3D printing, of course!