3D printed brain model for surgical simulation by Stratasys Direct Manufacturing.

The FDA just released new guidance for 3D-printed devices, seeking to clarify the pathway manufacturers must follow to get their products approved. This is the FDA’s latest attempt to keep pace with a fast-moving technology. A few weeks ago, the agency shared their emerging approach to molecular diagnostics.

But 3D printing, or additive manufacturing in agency nomenclature, offers its own unique regulatory challenges. The technology has long been a boon in the design process, driving rapid, iterative prototyping and evaluation. But with these approaches moving into the clinic, the agency felt the need to take further action.


“The FDA is concerned where there’s 3D technology in a device and being directly implanted in patients,” said Patrick Kullmann, founder and lead strategist at CG3 Consulting and president and COO at Medovex, in a phone interview. “Once you start a 3D printing process for an implantable heart valve, or implantable knee or hip, it’s a different story.”

FDA Commissioner Scott Gottlieb noted in a statement accompanying the guidance that 3D printing has the potential to manufacture drugs, fabricate skin grafts for burn victims and even provide replacement organs. The guidance seeks to help manufacturers better understand the agency’s requirements for device design, function, durability and quality as these applications move forward. But it’s also aimed at clinicians, who are developing their own devices.

“The FDA is saying that: If you’re altering devices or creating devices in a medical facility for use in a patient, this is a whole new frontier, and we are stepping up to provide some initial guidance as to what we’re looking for in these instances,” said Kullmann.

This technology has the potential to dramatically accelerate the product development process, forcing the FDA to keep up. Gottlieb’s statement notes the agency has built its own 3D-printing capabilities in The Center for Drug Evaluation and Research’s Emerging Technology Program.

Though 3D printing has unique capabilities to personalize care, such as providing custom-fitted orthopedic implants, it is not without precedent, giving the FDA something to build on.

“Over the last 10 years, we’ve created aortic stent grafting – an endograft that has compressible metal mesh that takes pressure off the artery,” said Kullmann. “These are custom-made for each patient, kind of like getting a custom pair of shoes.”

The FDA recognizes 3D printing is a moving target and is acting accordingly. The agency is also taking another look at bioprinting to complement its recently released regenerative medicine framework. Gottlieb’s statement also notes that, like 3D printing itself, regulation is an iterative process.

“But this technical guidance – categorized as a leap-frog guidance because it helps bridge where we are today with innovations of tomorrow – is only intended to provide the FDA’s initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways.”

Photo: Stratasys Direct Manufacturing