AAMI News January 2018

FDA Prepares for ‘Wave of New Technologies’ as 3D Printing Takes Off for Devices

The Food and Drug Administration (FDA) released its first-ever technical guidance concerning the additive manufacturing of medical devices in early December. Additive manufacturing is a burgeoning area of healthcare technology, which includes three-dimensional (3D) printing, that the agency believes is “nearly certain to transform medical practice.”

After reviewing more than 100 devices that were manufactured with 3D printers, the FDA is “preparing for a significant wave of new technologies.” It sees the new guidance as the first step toward 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 guidance document outlines recommendations for devices that include at least one additively manufactured component or additively fabricated step, including device design, testing for function and durability, and quality system requirements. The guidance does not address point-of-care device manufacturing or the incorporation of biological, cellular, or tissue-based products.

FDA Commissioner Scott Gottlieb categorized the guidance as “leap-frog guidance” in a statement “because it helps bridge where we are today with innovations of tomorrow.” This means the guidance is “only intended to provide the FDA’s initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways.”

“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,” Gottlieb said.

The FDA will hold a webinar on Jan. 10 to review the guidance document and answer questions.