Chris Krampitz, UL's Director of Strategy and Innovation for Additive Manufacturing Technologies recently shared his knowledge and experience with Additive Manufacturing of medical devices with Medical Design Outsourcing, a medical industry publication.
The article discusses the potential for variability and customization in 3D printing versus traditional manufacturing that makes the task of addressing compliance complicated.
The article also discusses recent FDA Guidance "Technical Considerations for Additive Manufactured Devices" including considerations for design and manufacturing and guidance on what to include in the 510(k) submissions. The article also points out that the FDA Guidance leaves out considerations for devices developed at the point-of-care, such as clinical settings and "It also doesn't address any biological, cellular, or tissue-based production using the technology, like bioprinting."
UL offers a full suite of services and resources to support device manufacturers using additive technologies. For more information, contact us at [email protected] or visit our specific pages using the links below.