New FDA guidance for companies that create 3D-printed implants in Orthopedics

More from the FDA on Material Characterization for Additive Manufacturing (ODTMag)
In March, I addressed here recent actions by the FDA to increase the specificity of material characterizations. That article focused on a February FDA Draft Guidance on UHMWPE used in orthopedic devices, and also mentioned a Guidance on blood access devices. Now, the FDA has again weighed in on material characterization, this time in the context of a Draft Guidance Document (DGD) on “Technical Considerations for Additive Manufactured Devices,” which includes 3D printing. The general issue of material characteriz...