FDA Holds 3D Printing Workshop

The FDA will hold a forum on the technical challenges associated with 3D printing in the medical device field October 8-9 at the agency's White Oak Campus in Silver Spring, MD.

An example of OPMs PEEK material at work. Courtesy of OPM.”

3D printing is steadily expanding its use in the medical field, with a number of companies developing 3D-printed medical implants and prosthetic devices. The FDA will hold a forum on the technical challenges associated with 3D printing in the medical device field October 8-9 at the agency’s White Oak Campus in Silver Spring, MD. The workshop will also be available as a webcast.

An example of OPM This 3D-printed facial implant received FDA approval earlier this year. Image: OPM

There will be a variety of speakers discussing both technical and clinical aspects of 3D printing in the medical field, including representatives from 3D Systems, the University of Michigan, STERIS, EIPI Systems, Renovis Surgical Technologies, Layerwise, and Stratasys.

While some existing 3D-printed medical devices have received approval under existing FDA regulations, other developing technologies may require new frameworks. At a presentation at MD&M East earlier in the summer, Steven Pollack, director of the Office of Science & Engineering Labs at the FDA, said that mechanical properties, biocompatibility, and interactive design are additive manufacturing considerations that the agency is monitoring.

For example, if physicians are able to print custom implants or prostheses themselves, who is identified as the manufacturer, and who is responsible for quality control?

Research firm IDTechEx expects the dental and medical market for 3D printers to expand by 365% to $867 million by 2025. If bioprinting becomes commercially viable, the medical market could reach $6 billion in 10 years.

The FDA has an additive manufacturing working group looking at these issues, and all of those areas of concern will be discussed at the upcoming workshop.

“[We would like to be] aware of the challenges and don’t regulate things that don’t need regulation,” Pollack said. “But we need to be aware of places where we need to take a deeper dive.”

To register for the workshop and view the agenda, click here.

Source: FDA

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Brian Albright

Brian Albright is the editorial director of Digital Engineering. Contact him at [email protected].

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