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FDA official announces coming communication about 3-D printing

By: Bill Bregar

May 12, 2014

CLEVELAND — The Food and Drug Administration is preparing a statement spelling out the agency’s position on 3-D printing for developing medical devices, a top FDA materials scientist said at the Plastics in Medical Devices conference in Cleveland.

3-D printing, also known as additive manufacturing, is becoming more commonly used to make medical prototypes, and patient models to help a surgeon prepare for an operations. But some speakers at the Plastics News-sponsored conference said 3-D printing is not yet suitable for making end-use biomedical products that go into the body.

FDA welcomes new technology and innovation for medical devices, said Benita Dair, deputy director of the Division of Chemistry and Materials Science in the Office of Science and Engineering Laboratories, at FDA’s Center for Devices and Radiological Health.

“FDA is aware of a lot of new game-changing technologies. But FDA does want to ensure safety and efficacy for the public. In terms of 3-D printing, I think we will soon put out a communication to the public about FDA’s thoughts,” Dair said, responding to a question. “We hope to help the market bring new devices to patients and bring them to the United States first. And we hope to play an integral part in that.”

Dair was a speaker May 7 at the two-day Plastics in Medal Devices conference, held at Cleveland Convention Center.