An Investigational New Drug designation is an authorization from the Food and Drug Administration (FDA) to administer a new drug or biological product to humans. It is the stamp of approval, represented by a 5 digit number, to enroll people in a clinical trial that closely monitors outcomes as well as any adverse events. It is important for all patients to be in a true, IND possessing, clinical trial so their outcomes can be easily evaluated. This way, the results data are available and can be compiled properly to accelerate a treatment’s development and support its marketability and insurance coverage in the United States.
Similar in purpose to an IND, an investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect safety and effectiveness data. Clinical studies conducted with the IDE stamp of approval can support obtaining premarket approval, and include clinical evaluation of any modifications or new intended uses of a legally marketed device. Clinical evaluations of investigational devices, unless exempt, must have an IDE before the study is initiated.