Newsteo certifies that the RF Monitor CFR 21 and RF Monitor Gold CFR 21 allow to fit the 21CFR part 11 requirements of the FDA (Food & Drug Administration). You can download the compliance certificate (here)
List of air-temperature data loggers approved for frozen food transportation. List updated in July 2018 and posted online by the French Ministry of Agriculture. You will find 2 Newsteo temperature data loggers in this list: the LOM16 and LOG36 which are both EN12830 certified.