New FDA’s draft guidance for 3D- printed medical devices

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New FDA’s draft guidance for 3D- printed medical devices

FDA has published a new draft guidance on Additive Manufacturing, also known 3D printing, which is a process that creates a three-dimensional object by building successive layers of raw materials. Each new layers is  attached to the previous one until the object is complete. Because of the innovative application of 3D-printed medical devices, this FDA’S draft guidance outlines technical considerations associated with the Additive Manufacturing and encourages manufacturers to engage with the Centre for Devices and Radiological Health (CDRH) to obtain more details regarding this topic.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf