---
kind: "section"
citation: "21 C.F.R. § 884.6120"
title: "21"
number: "884.6120"
heading: "Assisted reproduction accessories."
url: "https://uscodex.org/cfr/21/884.6120"
---

# §884.6120. Assisted reproduction accessories.

- (a) **Identification.** Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:
  - (1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
  - (2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
  - (3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
  - (4) **Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.**
  - (5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
- (b) **Classification.** Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation 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; 85 FR 44188, July 22, 2020]

### 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; 85 FR 44188, July 22, 2020]