part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
subpart_code: "G"
subpart_subject: "Assisted Reproduction Devices"
section_number: "884.6150"
section_subject: "Assisted reproduction micromanipulators and microinjectors."
cfr_reference: "21 CFR 884.6150"
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"
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(a)Identification. Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.
(b)Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).