Regulation Text
(a) Identification. Assisted reproduction micropipette fabrication devices are instruments intended to pull, bevel, or forge a micropipette or needle for intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) or other similar assisted reproduction procedures.
(b) Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.