Primary regulatory
FDA Guidance: General Labeling Considerations for Research Use Only (RUO) and Investigational Use Only (IUO) Products
FDA guidance on labeling requirements for Research Use Only (RUO) and Investigational Use Only (IUO) products, clarifying that RUO/IUO designations do not exempt products from FDA enforcement if therapeutic claims or human-use marketing is present.
U.S. Food and Drug AdministrationPublished 2018-07-26Accessed 2026-07-08
Registry record
Source metadata
- Publisher
- U.S. Food and Drug Administration
- Source type
- Primary regulatory
- Registry ID
fda-ruo-iuo-labeling-guidance
Source usage
Linked from 16 pages
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