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An Overview of Medical Device Regulations in the US
The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the...
FDA Proposes Major Changes to De Novo Pathway
De Novo classification, also known as Evaluation of Automatic Class III Designation, is a risk-based classification process of novel devices for which there are no legally marketed predicate devices. Under this...