We are going to distribute a foreign company's Chemilumenisent and ELISA analyzer which is an instrument and the intended use is for Research-Use-Only (RUO). So for a device that is for RUO, does this foreign manufacturer need to setup the FDA Estabishment Registration, and pay annual fee?
From FDA's definition for Foreign establishments, it appears it is not required if it's for RUO? The page says it is required if for health-related purpose commercial distribution
Who Must Register, List and Pay the Fee
From FDA's definition for Foreign establishments, it appears it is not required if it's for RUO? The page says it is required if for health-related purpose commercial distribution
Who Must Register, List and Pay the Fee
