Foley Partner David Rosen was quoted in an article that appeared in Genetic Engineering & Biotechnology News on October 12, 2011 titled “Extent of Feedback on RUO/IUO In Vitro Dx Draft Guidance Means Changes Not Expected Soon.” Rosen discusses draft guidance proposed by the FDA concerning the labeling of in vitro diagnostic (IVD) products marked “for research use only” (RUO) and “for investigational use only” (IUO). He states that some companies are concerned about what products they can sell as RUO/IUO tests and what they cannot under the FDA’s draft guidelines. Rosen recognizes the need for research, but notes that it is also important to ensure that people do not rely on tests that are not verified and validated.
