A test article is defined by the FDA as:
Note: Dietary supplements, foods, and other ingestibles are considered 'drugs' if they are utilized to diagnose, cure, treat, mitigate, or prevent a disease or condition.
Note: Some software, wearable technology, exercise devices, et al. may be classified as a medical device. Please refer to the FDA guidance on Digital Health Content for more information.
A clinical investigation, as defined by the FDA, is "any experiment that involves a test article and one or more human subjects"
The FDA defines human subjects as "an individual who is, or becomes, a participant in research, either as a recipient of the test article or as a control"
Note: de-identified human biological specimens used in this type of study qualifies as a human subject
The Code of Federal Regulations (CFR) Title 21 CFR is specific to rules and regulations of the FDA. Regulations pertaining to human subjects research include:
Regulatory language may be difficult to understand, especially for those who are new to reading these types of documents. However, it is mandatory that researchers and study teams understand the complex regulations surrounding IND/IDE trials. The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) site provides excellent guidance that many find accessible, and we recomnmend research teams start there.