In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. [21 CFR 809.3]

• Information about in vitro diagnostic products can be found on the FDA Office of In Vitro Diagnostic Device Evaluation and Safety at: http://www.fda.gov/cdrh/oivd/
• Researchers planning to conduct research involving IVDs must provide specific information to the IRB.
• Researchers should download DOH's Worksheet for Researchers: Research Involving In Vitro Diagnostic Investigations and provide all information required by the worksheet to the IRB using the online application system.
• researcher-worksheet-IVD.doc 44.50 kB