Zdrowie i gospodarka · 14.06.1996
Medical Devices; Classification/Reclassification of Immunohistochemistry Reagents and Kits
The Food and Drug Administration (FDA) is proposing to classify/reclassify immunohistochemistry reagents and kits (IHC's) (in- vitro diagnostic devices) into three classes depending on intended use. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) and the Safe Medical Devices Act of 1990 (the SMDA). The intention of this proposal is to regulate these pre- and post-1976 devices in a consistent fashion. Therefore, FDA is proposing classification or reclassification of these products as applicable.