For Now, Little Regulation of 3-D Printed Medical Devices
The U.S. Food and Drug Administration isn't in a rush to provide guidance for 3-D printed medical devices.
March 15, 2015 at 10:08 PM
2 minute read
The U.S. Food and Drug Administration isn't in a rush to provide guidance for 3-D printed medical devices, according to Bonnie Scott of Epstein Becker & Green in a recent post. She says that according to the agency's 2015 medical guidance agenda, 3-D is only a “B-list” priority.
Scott notes that comments from FDA officials indicate immediate guidance isn't necessary, and extensive specialized guidance may not be either. They view 3-D printing as manufacturing technology and “not something that exotic from what [the FDA has] seen before,” according to Steven Pollack, director of the FDA's office of science and engineering laboratories. He did, however, suggest manufacturers that want to market 3-D medical devices participate in presubmission meetings with the FDA. “Such meetings can help FDA reviewers get a better understanding of the technology involved in manufacturing the device, which is critical,” says Scott.
But the golden days won't last forever. “While this may be a way to bring some advances to the market, it seems like there are still regulatory challenges and uncertainties to address, which will likely only multiple as 3-D printed devices are developed for a greater variety of (and more complicated) uses,” she explains.
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