FAQs About Medical Device Studies A device is an instrument, machine, implant, in vitro reagent, or other similar article that: is intended for use in the diagnosis, treatment, or prevention of disease – and – does not achieve its primary intended purpose through chemical action in the body or by being metabolized. An investigational device exemption (IDE) allows the investigational...
Frequently Asked Questions About Drug Studies A drug is, among other things, an article (other than food) that: is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease is intended to affect the structure or any function of the body achieves its primary intended purpose through chemical action in the body or by being metabolized Biological...
IND Development Toolkit This section will help faculty navigate the process of developing a Sponsor-Investigator IND. The following article from the Journal of Investigative Medicine provides an overview: Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators (Holbein, M. E. Blair, Journal of Investigative Medicine. 57(6):688-694, August 2009). The information provided in the following links focuses on INDs...
