3D-Printed Medical Devices Spark FDA Evaluation | LiveScience:
"The FDA currently treats 3D-printed devices the same way it treats conventionally made medical devices, an FDA spokeswoman said.
"We evaluate all devices, including any that utilize 3D printing technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used," spokeswoman Susan Laine told LiveScience in an email. She added, "In some cases, we may require manufacturers to provide us with additional data, based on the complexity of the device." "
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