FDA Guidance on 3D Printing Medical Products Signals Future Regulation
The FDA's December 2017 guidance may be the first indication of new regulations around 3d printing.
December 29, 2017 at 01:29 PM
4 minute read
Recent non-binding guidance from the Food and Drug Administration (FDA) on the 3D printing of medical products is likely a sign that U.S. regulators are gearing up to release more suggestions in 2018 and beyond.
In December, the FDA released what the agency described as a “comprehensive technical framework” to advise manufacturers who are using 3D printers to create medical products, such as medical devices, medications and human tissue.
The FDA noted the guidance clarifies its recommendations for manufacturers on what to include in submissions for 3D-printed medical devices, as well as the agency's “thinking” on 3D printing product testing and device design.
Of the guidance, the FDA said, “Overall, it will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.”
In a statement, FDA Commissioner Scott Gottlieb said that the agency is “working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on these technologies.”
The FDA said that at present, it's working on a framework on how to apply current laws and regulations that govern device manufacturing to non-traditional manufacturers such as medical facilities and academic institutions that create 3D-printed personalized devices for specific patients getting treatment. The FDA also plans to review regulatory issues “on the bioprinting of biological, cellular and tissue-based products in order to determine whether additional guidance is needed beyond the recently released regulatory framework on regenerative medicine medical products.”
Yet regulating 3D printing may prove a long-term project. Jura Zibas, an attorney at Wilson Elser Moskowitz Edelman & Dicker, said there is no quick-moving effort to regulate 3D printing in the U.S.
“The FDA is the main agency at the moment looking to regulate 3D printing,” Zibas told Legaltech News. “Any products that fall under FDA regulation, 3D printing regulations will apply. 3D printing regulations within various industries and agencies will continue to expand given the consumer safety issues related to medical devices, as well as other products.”
Yet given the increasing reliance on such technology across different industries, it's difficult to determine how a regulatory framework will pan out.
“As the use of 3D printing grows, there will undoubtedly be more regulation proposed. 3D printing will impact many different areas of risk, so we cannot predict what regulations will pass on a federal or state level,” Zibas said. But, she cautioned, new technology “should not be controlled by legislators and regulators who are not fully familiar with the technology and its uses.”
“The concern related to overregulation is that it could stifle technological advancement. We need to assure the public is safe when using technology, but not curtail progress while other countries move forward and surpass our potential,” Zibas added.
Meanwhile, the European Union is also considering whether to enact new regulations in 3D printing technologies. The European Parliament's Committee on Legal Affairs has released a working paper on 3D printing, noting that the technology may raise legal, ethical, health and safety issues. Specifically, 3D printing raises intellectual property and civil liability issues.
Already, the FDA has reviewed more than 100 devices that were manufactured on 3D printers, such as knee replacements and implants that fit into a patient's skull for facial reconstruction. The FDA also approved the first drug produced on a 3D printer, which treats seizures. Additionally, more than a dozen pharmaceutical manufacturers have been in discussions with the FDA's Center for Drug Evaluation and Research regarding the use of 3D printing to manufacture drugs.
“This is likely just the tip of the iceberg given the exponential growth of innovative research in this field,” said Gottlieb, the FDA commissioner. “We envision that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs.” sometimes i add reminders of who the person was if they haven't been mentioned in awhile. but obviously, totally up to you.
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