{"entity":{"id":"research-use-only","kind":"term","name":"Research use only (RUO)","aka":["research use only","RUO","for research use only","not for diagnostic use","research-only notice","not for clinical use"],"tldr":"A research use only label means a test, reagent or model has not been validated or cleared for making decisions about a patient and must not be used that way.","summary":"The FDA's 2013 guidance describes in vitro diagnostic products labelled for research use only as products in the laboratory research phase of development, not intended for clinical diagnostic use, and sets out what manufacturers may and may not do when distributing them. The label travels with research models and datasets: a prediction shown as research only is not a clinical result, and a site that publishes such models has to say so on every page.","asOf":"2026-09-24","links":[{"label":"FDA guidance: Distribution of in vitro diagnostic products labeled for research use only or investigational use only (2013)","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/distribution-in-vitro-diagnostic-products-labeled-research-use-only-or-investigational-use-only"}],"tags":["cansim-terms"],"related":["cancer-ai-vocabulary"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["samd","analytical-vs-clinical-validation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Listed in the CanSim terms map 1.0.0 (docs/onco/terms.json, generated 2026-09-24), CC BY 4.0, attribution: CanSim project, an open, public-data-first cancer foundation-model programme; CanSim page path /terms/research-use-only."],"provenance":{"editedBy":"OnCo CanSim terms wave (Wikipedia summaries, standards and project pages, GDC and FDA pages, Europe PMC)","editedOn":"2026-09-24","note":"CanSim terms map 1.0.0 (docs/onco/terms.json, generated 2026-09-24), CC BY 4.0, attribution: CanSim project, an open, public-data-first cancer foundation-model programme"},"category":"Regulation & policy"},"route":"/terms/research-use-only/","neighbours":{"term":[{"id":"analytical-vs-clinical-validation","kind":"term","name":"Analytical versus clinical validation","route":"/terms/analytical-vs-clinical-validation/"},{"id":"cancer-ai-vocabulary","kind":"term","name":"Cancer AI vocabulary (CanSim terms map)","route":"/terms/cancer-ai-vocabulary/"},{"id":"model-card","kind":"term","name":"Model cards and datasheets for datasets","route":"/terms/model-card/"},{"id":"samd","kind":"term","name":"Software as a medical device (SaMD)","route":"/terms/samd/"}]}}