Medical devices; obstetrical and gynecological devices; classification of the assisted reproduction laser system. Final rule.
The Food and Drug Administration (FDA) is classifying the assisted reproduction laser system into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems." The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the guidance document that is the special control for this device.
D004867:Equipment Design; D004869:Equipment Safety / Q000145:classification; D005260:Female; D005307:Fertilization in Vitro / Q000145:classification / Q000295:instrumentation*; D006801:Humans; D007834:Lasers / Q000145:classification*; D027724:Reproductive Techniques, Assisted / Q000145:classification / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration