---
kind: "section"
citation: "21 C.F.R. § 884.6130"
title: "21"
number: "884.6130"
heading: "Assisted reproduction microtools."
url: "https://uscodex.org/cfr/21/884.6130"
---

# §884.6130. Assisted reproduction microtools.

- (a) **Identification.** Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.
- (b) **Classification.** Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 884.9](/cfr/21/884.9.md).

## Notes

### Amendments

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

### Source

Source: 63 FR 48436, Sept. 10, 1998, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

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