Part 58 applies only to nonclinical laboratory studies, which are defined as
in vivo or in vitro experiments in which test articles are studied prospectively in
test systems under laboratory conditions to determine their safety. The term does
not include studies utilizing human subjects or clinical studies or field trials in
animals. The term does not include basic exploratory studies carried out to
determine whether a test article has any potential utility or to determine physical
or chemical characteristics of a test article (21 CFR 58.3(d)).
Moreover, because the safety of IVDs is related to the accuracy of the result, most
IVD studies that are intended to establish safety would necessarily use human
specimens. As noted above, an IVD study using human specimens involves
human subjects and thus is excluded from the definition of nonclinical laboratory
studies. Such studies to establish safety are subject to 21 CFR Parts 50 and 56 and
21 CFR Part 812 as applicable, dealing with human subject research, rather than
to 21 CFR Part 58.
