By the new guidance about Additive Manufacturing devices, FDA wants to regulate the 3D printing manufacturing process of the devices.
At now his guidance refers to two of the most important steps of the manufacture and technical development of Medical Devices: the design controls and the production process.
With reference to GMP compliance, the identification and the analysis of each phase of the 3D printing process is recommended, from the initial phase of the product design until the post-production’s activities, and considering the impact of the manufacturing process on the device too.
Moreover, in the guidance the validation tests that must be executed on the device are defined, considering the intended use, the risk and the classification of the device.
Finally, the validation process can vary depending on the device technical features (i.e. implantable, custom-made) and dimensions.