On May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Technical Considerations for Additive Manufactured Devices” providing its initial thoughts on regulatory requirements for additive manufactured (AM) devices (aka 3D printed medical devices), the category of manufacturing that includes 3-dimensional (3D) printing. The FDA described this as a “leapfrog” guidance through which the Agency intends to provide its “initial thoughts” on this emerging technology, acknowledging that its recommendations may change as more information becomes available.
3D printing of medical devices is a process that builds an object layer-by-layer, joining each new layer to the one below. This process allows manufacturers to more easily develop and alter device designs, while also making complex and customizable medical devices more readily available. To address this technological innovation, the FDA is introducing standards for ensuring the quality and safety of AM medical devices, including determining optimal assessment methods for the final finished device, as well as process validation and acceptance methods.
While the draft guidance is not meant to be a comprehensive document addressing all regulatory requirements, it “outlines technical aspects of an AM device that should be considered through the phases of development, production process, process validation, and final finished device testing.” The guidance is split up into two categories of considerations: (1) design and manufacturing, and (2) device testing. Design and manufacturing considerations are intended to provide technical considerations that should be addressed when fulfilling quality system (QS) requirements for the finished device, while device testing considerations are intended to describe the type of information that should be submitted in premarket submissions for AM devices, recognizing that the type and amount of data needed to establish substantial equivalence or obtain approval will vary “depending on the intended use, risk profile, and classification and/or regulation for the device type.”
FDA necessarily cautions that “point-of-care manufacturing” — 3D printing of medical devices at doctor’s offices or hospitals – “may raise additional technical considerations not addressed in this guidance”.
FDA is requesting comments on the draft guidance by August 8, 2016.
To discuss how your company can begin to prepare for the regulation of 3D medical devices, contact Ann Marie Gaitan, Esq. at 786.440.8115 or via e-mail at email@example.com.