Additive Manufacturing Strategies

FDA Commissioner Releases Statement and New Guidance on 3D Printed Medical Devices

ST Medical Devices

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You can’t get anywhere with 3D printed medical products and devices in the US market without the extremely important approval of the Food and Drug Administration (FDA), an agency within the country’s Department of Health and Human Services. It takes a lot of hard work for a new medical innovation to receive FDA clearance, and not everything makes the cut – the agency has to consider things like whether or not the material is safe to be used around food and beverages. The FDA is constantly working with universities, researchers, and other industry officials to learn more about 3D printing, so they can be better equipped to issue guidance on 3D printed medical creations and, perhaps, eventually on 3D printers themselves.

The FDA itself makes use of the technology in its campus 3D printing facilities, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), in order to advance regulatory science with projects like the effect design changes could have on a device’s performance and safety, and figuring out how the process of 3D printing can impact the inactive ingredients of drugs.

Last May, the FDA released 3D printing draft guidance for medical manufacturers, and issued further guidance this winter relating to the technology. Today, FDA Commissioner Scott Gottlieb, MD, released a statement that details how the agency has been working with the new era of 3D printed medical products, noting that the FDA has already reviewed over 100 3D printed devices that are currently on the market, including patient-specific implants and knee replacements and the first 3D printed drug.

Scott Gottlieb, MD

“This is likely just the tip of the iceberg given the exponential growth of innovative research in this field,” Gottlieb said. “We envision that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs.”

The FDA has issued new guidance in order to advise medical device manufacturers on the technical aspects of 3D printing, as well as what specifically the agency recommends that manufacturers include on their 3D printed medical device submissions.

“It includes our thinking on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements,” Gottlieb explained. “Overall, it will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.”

The FDA is establishing a regulatory framework about how it plans to apply its existing device manufacturing regulations and laws to institutions and facilities that are 3D printing these devices, and according to a brief summary of Gottlieb’s statement, the agency is the world’s first to offer up a “comprehensive technical framework” that will offer manufacturers advice on 3D printing medical products.

“Developing a transparent policy on 3D printing remains an important next step for us, and we plan to explore the role of nontraditional manufacturing facilities like a hospital operating room or university laboratory,” Gottlieb said in his statement. “The FDA also plans to review the regulatory issues related to the bioprinting of biological, cellular and tissue-based products in order to determine whether additional guidance is needed beyond the recently released regulatory framework on regenerative medicine medical products.”

(L-R) 3D printed models of a brain, blood vessel, and surgical guide; (Bottom) medallion, printed on FDA 3D printers.

Gottlieb’s statement makes it clear that this new technical guidance was created only to offer the agency’s thoughts on 3D printing technology, and notes that any recommendations the FDA makes in regards to 3D printing “are likely to evolve as the technology develops in unexpected ways.”

“These steps are part of our broader effort to help ensure our regulatory framework is properly matched to the unique attributes of the new technologies we’re being asked to review,” Gottlieb concluded. “3D printing is certain to alter the daily practice of medicine where patients will be treated with medical products manufactured specifically for them. The FDA has an important mission to help advance these efforts while also protecting patients who depend on medical products to be safe and effective.”

You can take a look at the FDA’s most recent 3D printing guidance, and all of its other guidance documents, on the agency’s website.

Discuss this and other 3D printing topics at 3DPrintBoard.com or share your thoughts in the Facebook comments below. 

[Images: Food and Drug Administration]

 

 

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