Uncertainty Persists with RUO Products – FDA May Be Considering More Restrictive Approach with Research Use Only Assays

Research use only (RUO) products are ubiquitous in the life science industry. They are widely sold, prominently displayed at major conferences and routinely used by laboratories.

Yet, as common as RUOs are, their regulatory status is not well understood or defined. That is not surprising because they have long occupied an anomalous regulatory position.

Additional information available here.