Research

Research (as defined by FDA). Any experiment that involves a test article and one or more human subjects, and that meets any one of the following: Must meet the requirements for prior submission to the FDA under section 505(i) of the Federal Food, Drug, and Cosmetic Act, meaning any use of a drug other than the use of an approved drug in the course of medical practice, Must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act, meaning any activity that evaluates the safety or effectiveness of a device, Any activity the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit
Research (as defined by HHS). A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (Alliance Terminology & Data Resources May 2021)