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a new device to one that has already been cleared for sale by the agency. “The problem with that system is, if your device is new, innovative and quite a bit different from one already cleared by the FDA, then the FDA is going to treat it as a new device,” Schorre said. “They will initially default to classifying it as ‘high risk.’ You may have to [clear] significant hurdles so it can be a Class II product—to con- vince the FDA that it’s not high risk and doesn’t require clinical trials. But obvi- ously, just because a device is innovative and new doesn’t mean it’s high risk.”


US Regulators Try to Catch Up Because of the different European


approval system, “We sometimes advise clients to seek approval for their in- novative products in Europe first,” he said. “The regulatory system in Europe is rules-based and is therefore more flexible .... [G]oing to Europe first can be faster and cheaper because the manu- facturer might avoid having to jump through unexpected hoops that would be required for FDA clearance of an in- novative but lower risk device,” Schorre said. “Getting approval in Europe first will not necessarily make getting approval in the United States easier. The primary benefit is that companies making new technology can generate sales more quickly and be generating post market clinical use data that might eventually support a FDA submission.” In the future, clearance for mobile medical apps might be more well- defined in the United States. “The FDA is leading the charge in developing standards for mobile medical apps, but some want the FDA to take the next step in being more specific about what is allowed and what is not,” Schorre said. “That has not been happening in the rest of the world. Other countries will look at how the United States is regulating apps and issuing guidance


and most likely will emulate what the FDA has been doing. To their credit, the FDA understands they will always be a step behind in regulating mobile medical technology and do not want to be the ones to hinder its development.”


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June 2016 | AdvancedManufacturing.org 47


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