Technological advancements happen quickly in the medical device space-a fact the US Food and Drug Administration (FDA) has long struggled with as it seeks to stay abreast of cybersecurity threats and trends in mobile computing. But when it comes to one of the newest trends of all, 3-D printing, what is the agency planning on doing?
Guidance Coming in Less Than Two Years
Pay close attention in the next two years for the answer to that question, said Jeffery Shuren, director of FDA's Center for Devices and Radiological Health (CDRH), in response to Regulatory Focus at the AdvaMed 2013 meeting in Washington, DC.
"Our plan is to down the road put out guidance on 3D printing," Shuren said. "I'm hoping for less than two years."
Shuren: We're Staying 'Out of the Way' of Innovators
So what could that guidance look like? Focus asked Shuren if the guidance could draw parallels with CDRH's recently released mobile apps guidance, which seeks to regulate not the supporting technology (i.e. smartphones), but rather the end product that users interact with. With respect to 3D printing, could FDA take a similar approach, regulating just the end devices but not the 3D printers or the drafting files they construct devices from?
"It's much more in the manufacturing side [of guidance development]," Shuren added, hinting that the guidance may focus more on how 3D printing occurs-and with what materials-rather than addressing some of the more now-hypothetical regulatory questions, such as how FDA approaches regulation of devices that are made for personal use. "What you're making, and how you're making it, may have implications for how safe and effective that device is," he continued, 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 assured the audience, comparing the entire effort to the larger concept of personalized medicine. "We'd love to see that," he added, citing the example of a device that is customized to a specific person's unique needs.
Look to Custom Device Regulations for Clues
Regulators also said the issuance of the guidance could come sooner, since they already have a generally good grasp on the regulatory challenges they face.
"There are some bits of framework already in place from existing technologies," observed Joni Foy, deputy director for science and regulatory policy at CDRH's Office of Device Evaluation. Foy pointed to a lengthy history of custom devices, such as patient-matched implants, which are generally regulated less stringently than are other devices. "We're trying to have further discussions with regard to this issue," she said.
When asked later by an audience member if Shuren thought that the basic regulatory framework was already in place in the custom devices regulation, and that basic adjustments were needed, Shuren concurred. "That's our sense," he responded.
CDRH: We've Already got the Technology in Hand
Foy and Shuren also explained that many CDRH officials, particularly those within its testing laboratories, have been eager to analyze the issue of 3D printing. "We already have our own 3D printers," Shuren admitted. "Both for making things and understanding the new technology."
"We could provide a better pathway for those technologies that are used in 3D printing," Shuren said.