Obstetric and Gynecologic Devices: Reclassification of Medical Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures

摘要

The Food and Drug Administration (FDA) is proposing to reclassify instrumentation intended for use in in vitro fertilization (IVF) and related assisted reproduction procedures from class III to class II. FDA is also proposing to reclassify assisted reproduction microscopes and microscope accessories from class III to class I and to exempt this device from the requirement of premarket notification. This reclassification is being proposed on the Secretary of Health and Human Services' own initiative, based on new information. This action is 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).