P
PL.
Hello,
Does anyone know that whether or not could we removed the following sentence in the wording of intended use if our glucose meter is intended for both home and professional use? “it should not be used for diagnosis of diabetes”
And, is the sentence mandatory in FDA? what if our device is only for home use or only for professional use, then what will that be (can we remove the sentence in those two cases?)
Many thaks!!
Does anyone know that whether or not could we removed the following sentence in the wording of intended use if our glucose meter is intended for both home and professional use? “it should not be used for diagnosis of diabetes”
And, is the sentence mandatory in FDA? what if our device is only for home use or only for professional use, then what will that be (can we remove the sentence in those two cases?)
Many thaks!!