In late 2017, the Food and Drug Administration (FDA) introduced some non-binding guidance on 3D printed medical products. These regulations come with the anticipation that U.S. regulators are planning to release more guidelines in the new year and beyond. Last month, the FDA unveiled a “comprehensive technical frameworks” intended to aide manufacturers using 3D printing systems to produce medical products like medical devices, medication and human tissues.
According to the FDA, the guidance is meant to clearly define the manufacturing recommendations in regards to submissions of 3D printed products. In addition to this, they have been set to clarify the agency’s “thinking” on additive manufacturing product testing and device design.
The FDA stated, “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.”
FDA Commissioner Scoot Gottlieb also added 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.”
Sources at the agency say that currently, the FDA is laying down the framework for applying the existing laws and regulations that govern the manufacturing processes of non-traditional manufacturers such as the academic institutions and medical facilities that produce 3D printed, custom devices tailored to individual patients being treated. In addition to this, the FDA intends 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.”
Despite the noise being made by the FDA regulations, 3D printing may still end up being a long-term project. Jura Zibas, an attorney from Wilson Elser Moskowitz Edelman & Dicker, explains that this isn’t exactly a speedy process in the United States, unfortunately:
“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…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.” Zibas would go on to add, “The concern related to over regulation 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.”
The United States’ FDA isn’t alone in this regulatory process. The European Union is also considering forming new regulations for 3D printing technologies. The European Parliament’s Committee on Legal Affairs recently released a 3D printing working paper. There is some concern highlighted in the working paper, specifically related to legal, ethical, health and safety issues, but the FDA is beginning to put those concerns to bed after having reviewed over 100 3D printed medical devices such as knee replacements and implants. In addition to this, the first ever 3D printed drug – which treats seizures – was approved by the FDA. Adding even more, the FDA’s Center of Drug Evaluation and Research has been in talks with various pharmaceutical manufacturers about using 3D printing for the production of 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.”