As 3-D printers play a growing role in dentistry, industry organizations are working together with an eye on the potential regulations that will govern their use. For example, the Australian Dental Industry Association (ADIA) is collaborating with the government’s Therapeutic Goods Administration (TGA) to develop new regulatory standards for 3-D printed medical devices.
“Australia’s dental industry has proven itself to be an early adopter of 3-D printed medical devices, which has led the TGA to engage extensively with ADIA this matter,” said Troy Williams, ADIA chief executive officer. “We have a shared objective of ensuring that new regulations do not unnecessarily constrain this evolving technology.”
As discussions between members of ADIA and the TGA have continued, a shared understanding has developed that the current medical device regulatory framework may not adequately mitigate risks to patients, ADIA reports.
“This isn’t surprising as the current medical device regulatory framework was developed in an era when 3-D healthcare products, especially implantable medical devices, was not on the horizon of anyone back then,” said Williams.
ADIA’s goal is to ensure that the new regulatory framework is agnostic in its approach to the technology to enable various 3-D printing processes, such as material jetting, binder jetting, powder bed fusion, directed energy disposition, sheet lamination, and vat photopolymerization. ADIA also is working with the TGA to ensure the new regulatory framework suits existing technologies such as milling.
“The dental industry has proven itself, both within Australia and globally, to be an early adopter of pioneering patient diagnostic and patient treatment options,” said Williams. “It’s in this context we’re working with the TGA to ensure that new regulations do not constrain the use of new technologies.”
ADIA’s membership is working on the dental industry’s response to a TGA consultation paper outlining regulatory reform options, with the organizations meeting frequently to discuss the matter, according to ADIA.
“In our engagement with the TGA, the dental industry’s objective is to develop a regulatory framework for 3-D printed medical devices that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden,” said Williams.