PUD · Labware, Assisted Reproduction, Exempt
Obstetrics/Gynecology · 21 CFR 884.6160 · Class 2
Overview
| Product Code | PUD |
|---|---|
| Device Name | Labware, Assisted Reproduction, Exempt |
| Regulation | 21 CFR 884.6160 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.
Classification Rationale
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
