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Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. The greater the risk, the more likely a series of trials for market clearance or approval will be required. In other words, what are the risks and benefits of the product?
Medical device trials, however, are typically smaller in scale and require fewer phases [than drugtrials]. The information from this site goes on to describe how medical device studies are divided into three different classes, rather than into the familiar phases of drug studies.
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