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Comparing Drugs & Devices

How Are the Clinical Trials Regulated?

Once it is determined that a clinical trial is necessary, the applicable investigational new drug or medical device regulations will need to be followed. The regulatory requirements for conducting a clinical trial are exactly the same for drugs and devices in multiple facets, however, the differences exist in the investigational new drug regulations (21 CFR 312) and the investigational device exemption regulations (21 CFR 812). 

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