21 CFR 884.6100 — Needle, Assisted Reproduction
Obstetrics/Gynecology (OB) · Part 884 Subpart G—Assisted Reproduction Devices · § 884.6100
Identification
Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.
Classification Rationale
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MQE | Needle, Assisted Reproduction | 2 | 32 | 3rd Party |
| NNB | Needle, Reproduction, Assisted, Reprocessed | 2 | 0 | 3rd Party |
Special Controls
MQE — Needle, Assisted Reproduction
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
eCFR
MQE — Needle, Assisted Reproduction
mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing
Ecfr Llm
NNB — Needle, Reproduction, Assisted, Reprocessed
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
eCFR
