Three-dimensional printing has revolutionized the drug and device market and already has changed the lives of millions of patients. The FDA has reviewed more than 100 devices now on the market that were manufactured on 3-D printers, including knee replacements and implants “designed to fit like a missing puzzle piece into a patient’s skull for facial reconstruction,” says FDA Commissioner Scott Gottlieb, MD. The FDA also has approved the first drug produced on a 3-D printer. It has a more porous matrix than that of the drug manufactured in the traditional way, which allows it to dissolve more rapidly. But the technology advances have been moving so fast that they have threatened to outpace safeguards.
Now the FDA is preparing for a “significant wave” of new technologies, Gottlieb says, such as 3-D-printer skin cells for burn victims and is working to provide a regulatory pathway that keeps pace with those advances, helping to keep them safe and effective. To that end, the FDA has issued new guidance to help advise manufacturers on technical aspects of 3-D printing. And as more hospitals and academic centers use their 3-D printers for innovations to use in clinical studies, the FDA also is establishing a regulatory framework for applying existing laws to nontraditional manufacturers.
The Center for Drug Evaluation and Research state-of-the-art 3-D printing facility allows FDA scientists to conduct research to determine how 3-D printing of drugs, for instance, affects drug components. The Center for Devices and Radiological Health also has a 3-D printing facility to investigate the effect of design changes on safety and performance.
Gottlieb calls the technical guidance leapfrog guidance because it helps bridge current policy with innovation. It is only intended, he says, to provide “initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways.”