Zdrowie i gospodarka · 04/09/1997

FDA Proposes Reclassification of Medical Devices Used in IVF and Assisted Reproduction Procedures

The FDA is proposing to reclassify medical devices used in in vitro fertilization (IVF) and related assisted reproduction procedures from class III to class II, and to exempt certain devices from premarket notification requirements, based on new information and amendments to the Federal Food, Drug, and Cosmetic Act.