FDA-First Agency to Release a Guidance on 3D Printed Products

To keep up with evolving 3D printing technology and to encourage and support innovation in this field, the FDA has released it first technical guidance for manufacturers using 3D-printed technology for medical products that include devices, medication and human tissue.

The guidance provides a comprehensive policy framework to manufacturers and a more efficacious pathway to getting state-of-the-art medical products into the hands of patients and health care providers.

The new guidance clarifies the Agency recommendations on what 3D manufacturers need to include in their submissions as well as the agency’s thought process on “various approaches to 3D printing, such as device design, testing of products for function and durability, and quality system requirements.”

Currently most medical devices that are produced by 3D printing are orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics. For more information, please check the guidance here below.

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

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