StacksVerified U.S. regulatory reference

21 CFR §884.6140

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).