This page includes resources, literature, and terms related to Drug and Device Regulation. You can also review the interview from the online module here.

RESOURCES

LITERATURE

21 CFR 312 - Investigational New Drug (IND) Regulations
21 CFR 812 - Investigational Device Exemption (IDE) Regulations
Food, Drug, and Cosmetic Act
21st Century Cures Act

TERMS/GLOSSARY

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 (please note this interview is included in the eLearning assignment for this module)

Kristen Foss, Ph.D. | Senior Regulatory Affairs Scientist | Duke Office of Regulatory Affairs and Quality