Manufacturing Blog: How to Achieve Government Approval for Additive Manufacturing

Additive manufacturing (AM) is a fast-growing technology used for product research and development in several industries. However, for some organizations, it still faces the criticism of not being “good enough” for either commercial or military use. Additive manufacturers in the industries of medical devices and aerospace applications face a similar issue: government approval.
 
AM is still a young technology for manufacturing, even though the tech has been around for more than 40 years. When compared to traditional CNC machining or welding, 3D printing is still a toddler. Part of the problem with adopting an additive manufacturing process is how does one seek guidance on compliance.
 
To help bring some clarity to the conversation, the AM Industry Summit keynote topic on “Quality, Standards & Regulatory Considerations” focused on how one can seek approval for 3D-printed products from the Federal Aviation Administration (FAA) and the Food & Drug Administration (FDA). The conversation was hosted by Terry Wohlers, founder of Wohlers Associates, which produces The Wohlers Report, an annual state report on additive manufacturing celebrating its 25^th anniversary this year.
 
James Coburn, senior advisor for emerging technology at the FDA, and Matthew Di Prima, materials scientist for the FDA, stressed that the role of the FDA is to evaluate the end product and not necessarily the process.
 
“We approve and clear products. To clear a medical device or drug, we look at that process as part of the final approval, but it is not itself a certified process,” said Coburn. “As a comparison, you wouldn’t go into a factory and then put a stamp of approval on a process. You would evaluate the end product.”

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The same certification level exists at the FAA. According to Michael Gorelik, chief scientist at the FAA, the burden of proof on whether an additive manufacturing material or process is adequate falls on the manufacturing company.
 
“Most of the companies, if they want to produce their own parts, rely on their own internal company-specific material and process specification,” said Gorelik. “Whichever material and process specs they choose, they have to show to the FAA that those specifications provide an adequate level of control over the final product.”
 
Because of the technology’s infancy, the government regulations for 3D printing are still in the development phase. In 2017, the FAA and the FDA released roadmaps on how companies and engineers can receive government approval on 3D-printed parts. The documents offer technical guidance on how additive manufacturing can be used.
 
“The FDA has a 28-page guidance on technical considerations for using additive manufacturing for medical devices. We generally allow the worst-case device to be tested so that then we can say the rest of the sizes of the same device are approved,” said Di Parma. “If you can go through your process and demonstrate either one of the worst cases is valid, then a set of process parameters isn’t substantially going to change your product performance.”
 
When it comes to consulting industry standards, neither the FDA nor the FAA wants to dictate how companies use standards. What matters most is that the part is qualified for use, whatever standard is used.
 
“Part of the challenge right now is that AM is a relatively young technology. At the moment, there are a limited number of public standards out there, but that number is growing rapidly,” said Gorelik. “So it’s a matter of the company to use the most appropriate and capable standard, and then demonstrate that the specification is capable enough to ensure consistent quality and durability of those parts.”

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All three panelists agreed that the biggest misconception about additive manufacturing is that either organization is against the technology. On the contrary, both the FDA and the FAA welcome the expanse of 3D printing as a manufacturing tool. The real test is if the end product can meet all the qualifications of the parts that came before it.
 
“I often hear that the FDA doesn’t like additive or another advanced technology, and I think that it’s a big misconception,” said Coburn. “We’re agnostic to the use of any technology, as long as you can show us that it works.”
 
Carlos M. González is special projects manager.

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