Many industries have adopted 3D printing as a viable way to custom manufacture components on demand. But the healthcare industry has been slower to move into 3D printing, in part because the Food and Drug Administration hasn’t given medical device companies firm guidance about what the agency requires for products made in this manner. That’s changing. The FDA recently released draft guidance for companies that are working with devices that employ “additive manufacturing” – the process that most people call 3D printing.
The FDA intends its guidance to address design and development, as well as device testing, explains Regulatory Focus. That means that the forthcoming rules should give startup medical device companies a better sense of what they need to do in order ensure their product are in full compliance. But the FDA says that these new rules are not intended to cover any medical devices that contain biologics, cells, or human tissues.
The FDA has signaled openness toward 3D printing techniques. Steven Pollack, director of the FDA’s Office of Science and Engineering Laboratories, told Medical Device + Diagnostics Industry magazine that the agency views 3D printing as a manufacturing technology, not something exotic that regulators haven’t seen before. As a manufacturing technology, Pollack said that 3D printing fits with many of the agencies existing regulations governing medical device manufacturing. The FDA has granted marketing approval to least 85 medical devices made with 3D printing, most of them via existing review pathways, such as 510(k) clearance, he told MD+DI.
With the new guidance, the FDA says manufacturers must also identify each of the steps in the printing process – a requirement made necessary by the various technologies, printers, and materials used in this type of manufacturing. The FDA also says that a 3D printed product should perform the same as a non-3D printed device. For medical device designers and manufacturers, the bottom line is that the FDA is placing its emphasis on ensuring a device’s ability to perform its intended task – regardless of how it is made. That instruction gives medical device designers and manufacturers more clarity on what they need to do to pass regulatory muster.
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