FDA update – June 2, 2011

This draft guidance document is intended

• To clarify the types of in vitro diagnostic (IVD) products  that are properly labeled “for research use only” ("RUO") or “for investigational use only” ("IUO"), and
• To provide the responses of the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) to some frequently asked questions about how such products should and should not be marketed. This document is intended for manufacturers and distributors of RUO and IUO IVD products and any other entities who label IVD products.

RUO and IUO IVD products are distinctive in that they are devices that may themselves be used in research or investigations on human samples that may eventually lead to their clearance or approval for clinical diagnostic use, and they also may be marketed for and used in the research and investigation of other FDA-regulated products. 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. The manufacturer of such an IUO IVD product may legally distribute the product commercially without FDA premarket review, as long as the distribution is only for investigational use.

The marketing of unapproved and uncleared IVD products for purposes other than research or investigation (for example, for clinical diagnostic use) has led in some cases to diagnostic use of laboratory tests with unproven performance characteristics and manufacturing controls that are inadequate to ensure consistent manufacturing of the finished product.

Use of such tests for clinical diagnostic purposes may mislead healthcare providers and cause serious adverse health consequences to patients, who are not aware that they are being diagnosed with research or investigational products. FDA is therefore issuing this guidance to remind manufacturers of the requirements applicable to RUO and IUO IVDs.

Pursuant to 21 CFR 809.10(c), shipments and other deliveries of IVDs are exempt from the IVD labeling requirements at section 809.10(a) and (b) if either (1) there has been compliance with part 812, or (2) the investigation is not subject to part 812 and one of the following conditions is met:  

(i) For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently placed: "For Research Use Only. Not for use in diagnostic procedures.''

(ii) For a product being shipped or delivered for product testing prior to full commercial marketing (for example, for use on specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful), all labeling bears the statement, prominently placed: "For Investigational Use Only. The performance characteristics of this product have not been established.''

For more information on this guidance you can go to the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM257460.pdf or contact mdi at info@mdiconsultants.com REF: New Draft Guidance for RUO or IUO.