Clinical trials are the pathway for new drugs or devices to enter the U.S. and other worldwide markets. However, not all clinical trials are the same. A recent article by a 20+ year insider in the clinical trial industry said: “While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed. When studying new drugs, a clinical trial is required. However, when studying medical devices, clinical trials may not be required, depending on the risk stratification (or class) of the device.
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