21 CFR § 884.6150 - Assisted reproduction micromanipulators and microinjectors.

---
identifier: "/us/cfr/t21/s884.6150"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.6150 - Assisted reproduction micromanipulators and microinjectors."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.6150"
section_name: "Assisted reproduction micromanipulators and microinjectors."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "884"
part_name: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "45 FR 12684, Feb. 26, 1980, unless otherwise noted."
cfr_part: "884"
---


# 884.6150 Assisted reproduction micromanipulators and microinjectors.

(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). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]