"What is an investigational new drug and an investigational device exemption?”
The term investigational new drug (IND) refers to a drug or biological product that will be or is being used in a clinical investigation, having already been tested in a laboratory and authorized by the FDA for use in humans in a research setting following successful submission and review of an Investigational New Drug Application.
Similarly, an FDA-approved investigational device exemption (IDE) allows researchers to use an investigational device in a clinical study to collect safety and effectiveness data, following successful submission and review of an Investigational Device Exemption Application.