Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices
- 3 August 2015
- journal article
- review article
- Published by Wiley in Clinical and Translational Science
- Vol. 8 (5), 594-600
- https://doi.org/10.1111/cts.12315
Abstract
Three-dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D-printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D-printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D-printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D-printed bioresorbable implantable device.Keywords
Funding Information
- NIH (R21 HD076370-01, T32 DC005356-12)
- National Center for Advancing Translational Sciences of the National Institutes of Health (2UL1TR000433)
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