FDA releases draft guidance for RUO/IUO IVDs
Posted: June 3, 2011

FDA has issued a draft guidance stating its recommended practices for using and marketing IVD tests for research and investigational uses only. "Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions" is now available for public comment. The document is "intended for manufacturers and distributors of RUO and IUO IVD products and any other entities who label IVD products," FDA says on its Web site.

The document aims to clarify what types of IVD products are labeled "for research use only" (RUO) and "for investigational use only" (IUO), and how FDA believes they should be used and marketed. The guidance does not introduce new enforceable policies.
The guidance seems to suggest that FDA would prefer that companies selling RUO/IUO IVDs stop selling their tests to customers who may be using them for clinical applications.
The document covers tests that are in the lab-research phase of development and tests that are being shipped for product testing prior to full commercial marketing. It provides answers (developed by CDRH and the CBER) to common questions about RUO/IUO marketing practices.
FDA issued the guidance to remind makers of these tests how they are to be used and marketed and to clarify the RUO and IUO distinctions, which enable the sale of tests without FDA premarket review, so long as they are not being sold for clinical use.

On its Web site, FDA takes the following position on RUO/IUO products being used in clinical settings:

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. 

--Maureen Kingsley, associate editor

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