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Home » FDA Official Reiterates RUO Rules, Promises Enforcement Discretion
FDA Official Reiterates RUO Rules, Promises Enforcement Discretion
Manufacturers of diagnostics designated for research or investigational use only should limit their use to the earliest stages of device development, Alberto Gutierrez, director of CDRH’s Office of In Vitro Diagnostics and Radiological Health, said during a Wednesday webinar sponsored by the American Association for Clinical Chemistry.