FDA Issues Final Guidance on Additive Manufactured (“3D-Printed”) Devices

By Rachel E. Hunt & Allyson B. Mullen — On December 5, 2017, FDA issued a final guidance: Technical Considerations for Additive Manufactured Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Additive Manufacturing (AM) is “a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers to rapidly alter designs without the need for retooling and to create complex devices built as a single piece.”  This includes so‑called 3D printing.  FDA issued a draft of this guidance in May 2016, as discussed in our prior blog post here. This post discusses the main differences between the draft and final guidance.  For a more in depth overview of the entire content, please refer to the prior blog post. The guidance provides insight into the unique considerations of AM manufacturers in complying with quality system regulations and device…

Read more detail on Recent Products Liability posts –

This entry was posted in Products Liability and tagged , , , , , , . Bookmark the permalink.

Leave a Reply