Obstetric and gynecologic devices; reclassification and classification of medical devices used for in vitro fertilization and related assisted reproduction procedures--FDA. Final rule.
The Food and Drug Administration (FDA) is announcing that it is reclassifying instrumentation intended for use in in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures, including but not limited to gamete intrafallopian transfer (GIFT), embryo transfer (ET), and intracytoplasmic sperm injection (ICSI), from class III (premarket approval) to class II (special controls). FDA is also reclassifying assisted reproduction microscopes and microscope accessories from class III to class I. This reclassification is on the Secretary of the Department of Health and Human Services' (the Secretary's) own initiative based on new information. Accordingly, the order is being codified in the Code of Federal Regulations. Upon the effective date, this Federal Register document may be cited in the absence of an existing predicate device which would be used to support substantial equivalence. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance entitled "Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k)."
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000145:classification*; D005307:Fertilization in Vitro / Q000295:instrumentation*; D006801:Humans; D018456:Reproductive Medicine / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration