Is there a regulation that specifically addresses labeling of IVD products?
Yes. The regulation, “Labeling for in vitro diagnostic products,” (21 CFR 809.10), specifies the information required on labeling and in package inserts of marketed products as well as products in development that are distributed for use in studies. We recommend that you design IVD studies so that the results will support the proposed indications for use in the package insert and labeling.
