eCFR Reference Browser

---

title: "21 CFR §884.6140"

source: "https://www.ecfr.gov/current/title-21/section-884.6140"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "884"

part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"

subpart_code: "G"

subpart_subject: "Assisted Reproduction Devices"

section_number: "884.6140"

section_subject: "Assisted reproduction micropipette fabrication instruments."

cfr_reference: "21 CFR 884.6140"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

§884.6140 - Assisted reproduction micropipette fabrication instruments.