The FDA has issued new guidance on the use of 3D printing in response to the technology’s growing adoption by the healthcare industry.
3D Printed ball
FDA commissioner Scott Gottlieb said in a statement: “Today we are issuing new guidance to help advise device manufacturers on technical aspects of 3D printing, referred to as additive manufacturing, that clarifies what the FDA recommends manufacturers include on submissions for 3D-printed medical devices.”
The guidance covers the technical aspects of 3D printing, such as device design, considerations for device testing and quality system requirements. It is intended to convey the FDA’s initial thoughts on the emerging technology and offer non-binding recommendations on how best to approach the various aspects of additive manufacturing.
As the technology develops, the FDA’s recommendations “are likely to evolve as the technology develops in unexpected ways.” Gottlieb states. More so, the FDA is working towards a regulatory pathway that will speed up access to technologies based on 3D printing.
Gottlieb references how 3D printing is now being used to help develop devices that are patient-specific such as knee replacements and implants. The FDA commissioner also discusses the potential future advancements that 3D printing will allow. These include 3D printed skin cells that can directly treat burn wounds and the use of the technology to develop replacement organs.
With the technology beginning to be used in hospitals and academic centres, the FDA is working to establish a regulatory framework that ensures the safety and effectiveness of any product 3D printed by these institutions. Gottlieb states that the framework “will apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating.”
Gottlieb goes on to say that the efforts the FDA is taking will “help ensure our regulatory framework is properly matched to the unique attributes of the new technologies we’re being asked to review. 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.”