FDA Posts on its Website, then Removes, Draft Guidance that would Restrict Research Use Only, Investigational Use Only Status

By Jamie K. Wolszon –

Trade reports recently indicated that FDA intended to issue by the end of May a draft guidance outlining its policy for “Research Use Only” (“RUO”) and “Investigational Use Only” (“IUO”) products such as reagents and instruments.  Last week FDA posted on its website a draft guidance setting forth its vision on the appropriate sale and distribution of those products.  (A copy of that draft guidance is available here.)  FDA later removed the document from the website, but not before multiple companies had obtained and circulated the document widely.  It is unclear what will be in the draft RUO/IUO guidance if and when FDA issues the document.  The agency may make revisions to the document that was posted last week.   

However, if adopted in the form it was posted, the document is likely to generate some controversy regarding a number of aspects.  Two of the elements that are particularly likely to draw attention are: (1) FDA states that if a manufacturer is aware that a customer is using the RUO or IUO product for diagnostic purposes, that the manufacturer should “halt” selling the product to the customer; (2) FDA states that products “intended for use in non-clinical laboratory research with goals unrelated to development of a commercial product, such as discovering and developing novel and fundamental medical knowledge related to human disease and conditions,” could qualify as RUO, along with RUO products intended to further refine or develop the assay.  This caveat that RUO eligibility depends on being intended to develop “novel and fundamental medical knowledge” is a tightening of FDA’s definition of RUO.