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FDA Releases Guidance on Research Use, Investigational Use Only IVDs

NEW YORK (GenomeWeb News) – The Food and Drug Administration has released a guidance document that lays out and clarifies the rules for how in vitro diagnostic products for research use only (RUO) and investigational use only (IUO) may be used, labeled, or marketed.

FDA created the guidance on RUOs and IUOs, which has been in development for several years, because it is concerned that unapproved or uncleared IVDs are being used for clinical diagnostic use, even though their performance characteristics and manufacturing controls have not met the agency's clinical standards.

The agency allows an investigational device exemption (IDE) for medical devices that enables them to be used in research without receiving premarket approval or 510(k) clearance, but a lack of clarity in the exemption has created a loophole that makes it possible for RUOs and IOUs to seep into clinical use.

The worry is that healthcare providers could be misled about the approved applications for RUO and IUO tests, and patients could be harmed. To avoid such harms, FDA wants this guidance to inform IVD makers on how to comply and ensure that devices are being used as they were intended.

The new FDA document covers the appropriate and inappropriate uses for IVDs, as well as requirements for their labeling, manufacturing, and marketing.

To qualify as an IDE, devices must be non-invasive, must not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic, and must not require an invasive sampling procedure that presents a risk.

The guidance states that RUOs must be labeled, "For Research Use Only. Not for use in Diagnostic Procedures." IUOs must be labeled, "For Investigational Use Only. The performance characteristics of this product have not been established.''

Product labeling alone may not keep IVDs from being marketed for clinical uses, so the guidance provides details regarding how the RUOs and IUOs may be marketed, and the kinds of promotional statements that would conflict with the devices' RUO and IUO status.

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