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 That article focused on a February FDA Draft Guidance on UHMWPE used in orthopedic devices, and also mentioned a Guidance on blood access devices. Now, the FDA has again weighed in on material characterization, this time in the context of a Draft Guidance Document (DGD) on “Technical Considerations for Additive Manufactured Devices,” which includes 3D printing.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 characterization is how much needs to be specified to know exactly what material is being used in a medical device, and to address whether one material is identical or similar to another material. If similar rather than identical, how similar is it? Is that degree of similarity sufficient to apply experience with one material to expected performance of the other? These issues apply to both the raw materials and those materials as manufactured into a device.
In the DGD, the FDA “recommends,” or is thinking about recommending (since this is a draft) that material specifications begin with the identity of t...
