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.
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