The US Food and Drug Administration (FDA) has issued final guidance, Technical Considerations for Additive Manufactured Medical Devices, to clarify what the FDA recommends manufacturers include on submissions for 3D-printed medical devices.

The technical guidance, categorized by the FDA as a “leap-frog” guidance because it helps bridge current and future technology, is intended to provide the FDA’s initial thoughts on an emerging technology with the understanding that its recommendations are likely to evolve as the technology develops.

The guidance includes the FDA’s thinking on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements. Overall, the FDA says the guidance will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure the agency’s regulatory approach is properly tailored to the opportunities and challenges posed by the new technology.

The FDA says it has reviewed more than 100 devices currently on the market that were manufactured on 3D printers. These include patient-matched devices tailored to fit a patient’s anatomy. Examples include knee replacements and implants designed to fit into a patient’s skull for facial reconstruction, and in the future may include replacement organs. The agency noted that it approved the first drug produced on a 3D printer, Aprecia Pharmaceuticals’ Spritam (levetiracetam), a drug to treat certain types of seizures, in 2015. The drug uses 3-D printing to bind multiple layers of a powder blend using an aqueous fluid to produce a porous, water-soluble matrix in a pill that disintegrates with a sip of liquid.

FDA Commissioner Scott Gottlieb said in a statement that to help advance the use of 3D printing by pharmaceutical companies, the FDA’s Center for Drug Evaluation and Research’s (CDER) offers an Emerging Technology Program, which provides opportunities for early engagement regarding innovative approaches to pharmaceutical product design or manufacturing, including 3D manufacturing of pharmaceuticals. The FDA says more than a dozen pharmaceutical manufacturers have formally or informally been in contact with CDER regarding the use of 3D printing to manufacture drugs.

The FDA said it has 3D-printing facilities located at CDER to enable FDA scientists to conduct research to determine how the 3D printing of drugs impacts inactive ingredients and other drug components as well as the quality control process of manufacturing.

The FDA is also working to establish a regulatory framework for how it plans to apply existing 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 they are treating. “Developing a transparent policy on 3D printing remains an important next step for us, and we plan to explore the role of nontraditional manufacturing facilities like a hospital operating room or university laboratory,” Gottlieb said in a statement.

The FDA also plans to review the regulatory issues related to 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.

Source: FDA (statement) and FDA (guidance)