Am I required to follow the “Good Laboratory Practice for Nonclinical Studies” regulation (21 CFR Part 58) in my IVD study?
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 Parts 50 and 56 dealing with human subject research, rather than to Part 58.
