Guidance

Test Articles in Research

IRBMED
Apr 17, 2012 2:15 pm

The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products.

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Edited By: mhayward@umich.edu
Last Updated: May 23, 2018 8:00 AM