Zomedica Corp (ZOM)

[Raffis]

See pp. 7 https://www.fda.gov/media/87374/download

“III.Research Use Only and Investigational Use Only In Vitro Diagnostic Products
Both RUO and IUO products are IVD products currently under development and not approved for clinical diagnostic use. Because they are being shipped for investigations pertaining to product development and not clinical use, these products are exempt from most regulatory controls including IDE regulation. The term RUO refers to devices that are in the laboratory phase of development. The term IUO refers to devices that are in the product testing phase of development.
A. Research Use Only In Vitro Diagnostic Products
An RUO product is an IVD product that is in the laboratory research phase of development and is being shipped or delivered for an investigation that is not subject to part 812. During the research phase of development, the focus of manufacturer-initiated studies is typically to evaluate design, limited-scale performance, and issues such as usability of the test. Some examples of products FDA would consider to be in this research phase include:
• Tests that are in development to identify test kit methodology, necessary components, and analytes to be measured.
• Instrumentation, software, or other electrical/mechanical components under development to determine correct settings, subcomponents, subassemblies, basic operational characteristics, and possible use methods.
• Reagents under development to determine production methods, purification levels, packaging needs, shelf life, storage conditions, etc.
FDA also recognizes that there are certain products, such as instruments, systems, and reagents that are labeled for research use only and intended for use in the conduct of non- clinical laboratory research with goals other than the development of a commercial IVD product, i.e., these products are used to carry out research and are not themselves the object of the research. These include products intended for use in discovering and developing medical knowledge related to human disease and conditions. For example, instruments and reagents intended for use in research attempting to isolate a gene linked with a particular disease may be labeled for research use only when such instruments and reagents are not intended to produce results for clinical use.”