May 17, 2014
The Food and Drug Administration (FDA) is preparing a meeting to discuss about the technical challenges and solutions of 3-D printing as well as the agency's position on 3D printing for developing medical devices.
3D printing has been used to make medical devices and patient models. FDA noted that it has begun to receive submissions using additive manufacturing for both traditional and patient-matched devices, and it expects more to emerge in the future.
Dr. Steven Pollack (left) and Research engineer James Coburn (right) in the FDA lab. Image: FDA
However, there are still wide concerns that the technology is not yet ready for making devices or body parts that go into the body. "There are technical challenges associated with the process from design to final product that need to be properly addressed in all cases to ensure patient safety and to promote innovation in a fast-moving field." noted FDA.
At the plastics in Medical Devices conference in Cleveland recently, 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, said that the agency will soon put out a communication to the public.
"In terms of 3D printing, I think we will soon put out a communication to the public about FDA's thoughts," Dair said, according to Plastics News. "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."
On May 19, 2014, FDA announced it will hold a public workshop entitled "Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing" in October 2014.
The purpose of this workshop is to provide a forum for FDA, medical device manufactures, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3-D printing. The Agency would like input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.
And ideas generated during this workshop may facilitate development of new draft guidances and/or standards for additive manufacturing of medical devices, says FDA.
But the notice also indicates the specific printing technologies or medical device types will still be covered by their existing standards and guidance documents.
Topics for Discussion
- Preprinting considerations, including material chemistry, physical properties, recyclability, part reproducibility and process validation.
- Printing considerations, including printing process characterization, software used in the process, post-processing steps (hot isostatic pressing, curing) and additional machining.
- Post-printing considerations, including cleaning/excess material removal, effect of complexity on sterilization and biocompatibility, final device mechanics, design envelope and verification.
The public workshop will be held on October 8 and 9, 2014 at the FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993.
Posted in 3D Printing Applications
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So can we regulate table saws, hammers, band saws, cutting torches since they are tools also? I mean seriously a 3D "printer" is a tool.
TheOne wrote at 5/18/2014 11:09:59 AM:
Who cares what about them.
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