Drug & Device Regulation

In the U.S. the Food and Drug Administration (FDA) is the agency within the Department of Health and Human Services that is tasked with protecting public health by ensuring the safety and effectiveness of commercialized products, including pharmaceuticals, medical devices, veterinary medicines, and cosmetics. Regulatory professionals at clinical and translational research institutions and beyond help ensure the safety of FDA regulated products that are tested within their organization.

The course below provides an overview of how the FDA regulates drugs and medical devices that are tested using clinical trials.

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Resources

Resources and literature related to regulation of medical products

Resources: Literature: 
Terms and definitions related to regulation of medical products

Drug: an article that is intended:
  • for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease OR
  • to affect the structure or any function of the body
Biologic: the definition of a drug also includes biological products or biologics. Biologics are a diverse category of products that differ from traditional small-molecule drugs in that they are generally large, complex molecules that may be isolated from a natural source or produced through biotechnology in a living system.

Medical Device: an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent or other similar or related article or component, part, or accessory which:
  • Is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease OR
  • Is intended to affect the structure or any function of the body; AND
  • Does not achieve any of its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
For more information on how to determine if a product is classified as a medical device, please refer to FDA’s Device Determination Steps.

Investigational Device Exemption (IDE): a regulatory submission to the FDA that permits a significant-risk clinical investigation of a device.

Investigational New Drug (IND): a regulatory submission to the FDA that permits the clinical investigation of a drug.

Interview

Kristen Foss, Ph.D.

Senior Regulatory Affairs Scientist 

Duke Office of Regulatory Affairs and Quality