Posted 16 May 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) plans to soon hold a meeting to discuss the future of regulating medical products made using 3D printing techniques, it has announced.
3D printing is a manufacturing process which layers printed materials on top of one another, creating three-dimensional parts (as opposed to injection molding or routing materials).
The manufacturing method has recently come into vogue with hobbyists, who have been driven by several factors only likely to accelerate in the near future:
- The cost of 3D printers has come down considerably.
- Electronic files which automate the printing process are shareable over the Internet, allowing anyone with the sufficient raw materials to build a part.
- The technology behind 3D printing is becoming more advanced, allowing for the manufacture of increasingly durable parts.
While the technology has some alarming components—the manufacture of untraceable weapons, for example—it's increasingly being looked at as the future source of medical product innovation, and in particular for medical devices like prosthetics.
Promise and Problems
But while 3D printing holds promise for patients, it poses immense challenges for regulators, who must assess how to—or whether to—regulate the burgeoning sector.
In a recent FDA Voice blog posting, FDA regulators noted that 3D-printed medical devices have already been used in FDA-cleared clinical interventions, and that it expects more devices to emerge in the future.
Already, FDA's Office of Science and Engineering laboratories are working to investigate how the technology will affect the future of device manufacturing, and CDRH's Functional Performance and Device Use Laboratory is developing and adapting computer modeling methods to help determine how small design changes could affect the safety of a device. And at the Laboratory for Solid Mechanics, FDA said it is investigating the materials used in the printing process and how those might affect durability and strength of building materials.
And as Focus noted in August 2013, there are myriad regulatory challenges to confront as well. For example: If a 3D printer makes a medical device, will that device be considered adulterated since it was not manufactured under Quality System Regulation-compliant conditions? Would each device be required to be registered with FDA? And would FDA treat shared design files as unauthorized promotion if they failed to make proper note of the device's benefits and risks? What happens if a device was never cleared or approved by FDA?
The difficulties for FDA are seemingly endless.
Plans for a Guidance Document
But there have been indications that FDA has been thinking about this issue extensively.
In September 2013, Focus first reported that CDRH Director Jeffery Shuren was planning to release a guidance on 3D printing in "less than two years."
Responding to Focus, Shuren said the guidance would be primarily focused on the "manufacturing side," and probably on how 3D printing occurs and the materials used rather than some of the loftier questions posed above.
"What you're making, and how you're making it, may have implications for how safe and effective that device is," he said, explaining how various methods of building materials can lead to various weaknesses or problems.
"Those are the kinds of things we're working through. ‘What are the considerations to take into account?'"
"We're not looking to get in the way of 3D printing," Shuren continued, noting the parallel between 3D printing and personalized medicine. "We'd love to see that."
Guidance Coming ‘Soon’
In recent weeks there have been indications that the guidance could soon see a public release. Plastics News reported that CDRH's Benita Dair, deputy director of the Division of Chemistry and Materials Science, said the 3D printing guidance would be announced "soon."
"In terms of 3-D printing, I think we will soon put out a communication to the public about FDA’s thoughts,” Dair said, according to Plastics News. “We hope to help the market bring new devices to patients and bring them to the United States first. And we hope to play an integral part in that.”
But FDA has now announced that it may be awaiting public input before it puts out that guidance document. In a 16 May 2014 Federal Register announcement, the agency said it will hold a meeting in October 2014 on the "technical considerations of 3D printing."
"The purpose of this workshop is to provide a forum for FDA, medical device manufacturers, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3-D printing. The Agency would like input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions."
That language—"transparent evaluation process for future submissions"—indicates that at least one level, FDA plans to treat 3D printing no differently than any other medical device, subjecting the products to the same rigorous premarket assessments that many devices now undergo.
FDA's notice seems to focus on industrial applications for the technology—not individual ones. The agency notes that it has already "begun to receive submissions using additive manufacturing for both traditional and patient-matched devices," and says it sees "many more on the horizon."
Among FDA's chief concerns, it said, are process verification and validation, which are both key parts of the medical device quality manufacturing regulations.
But the notice also indicates that existing guidance documents, such as those specific to medical device types, will still be in effect regardless of the 3D printing guidance.
FDA's proposed list of discussion topics include:
- Preprinting considerations, including but not limited to:
- material chemistry
- physical properties
- part reproducibility
- process validation
- Printing considerations, including but not limited to:
- printing process characterization
- software used in the process
- post-processing steps (hot isostatic pressing, curing)
- additional machining
- Post-printing considerations, including but not limited to:
- cleaning/excess material removal
- effect of complexity on sterilization and biocompatibility
- final device mechanics
- design envelope
One final interesting note: FDA's notice describes 3D manufacturing as being similar to "building with interlocking bricks." In other words, LEGOs.
Federal Register Notice