IUO definition

IUO means an Assay that is labeled for “investigational use only”.
IUO means an assay for investigational use only that meets certain clinical and manufacturing standards and which is used in clinical studies to gather data for submission to a Regulatory Agency in support of an Approved Assay.
IUO or “Investigational Use Only” means an IVD for investigational use only that meets certain clinical and manufacturing standards and that is used in clinical studies (that are exempt from FDA’s Investigational Device Exemption or IDE regulations, 21 C.F.R. 812) to gather data for submission as required by the FDA or another Regulatory Authority to obtain Regulatory Approval of such IVD as an Approved IVD.

Examples of IUO in a sentence

  • The term IUO refers to devices that are in the product testing phase of development.”56 IUO products may be used in research testing on human samples and the research may eventually lead to the clearance, approval, or licensure of a new IVD for clinical diagnostic use.

  • For clarity, while the Ventana CAP/CLIA laboratory is qualified to be a testing lab for pivotal studies, it is Ventana’s recommendation that the Ventana IUO be transferred to a commercial laboratory(ies) other than Ventana’s CAP/CLIA certified laboratory for use in registrational Clinical Trials.

  • The Ventana IUO will be transferred and validated at those labs, and the lab pathologists trained and qualified by Ventana prior to enrollment for those pivotal Clinical Trials.

  • A diagnostic clinical trial protocol will be written and a clinical site initiation visit (“SIV”) will be completed at the start of each Clinical Trial, to ensure proper data capture and operations to support the clinical development of the IUO.

  • If the Ventana IUO is not ready to be transferred to commercial laboratories for the start of an BLU-554 pivotal study, Blueprint and Ventana will negotiate in good faith the terms of separate Project Schedules (i) for patient screening using the prototype Ventana Assay at Ventana’s CAP/CLIA laboratory and (ii) any resulting bridging studies that are required for the Ventana Assay to gain Regulatory Approval.

  • Some of the reagents, instruments, software or components obtained by us from suppliers for use in our products are currently labeled as RUO or IUO.

  • Thus, the manufacturer of an IUO IVD product is not necessarily the sponsor of a clinical investigation that uses such an IVD product in a study.

  • LymPro is already being made available to the AD research and development community under an Investigational Use Only (IUO) designation via a services agreement between Amarantus and Icon Central Laboratories.

  • If the LDT is not clinically validated and is the object of the clinical investigation, FDA likely would apply its clinical research regulations to the conduct of that study.In general, an IVD may be intended for research use only (RUO) or investigational use only (IUO).

  • In November 2013, the FDA finalized guidance regarding the sale and use of products labeled RUO or IUO.


More Definitions of IUO

IUO means Products labeled “investigational use only.”

Related to IUO

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