Obstetrical and Gynecological Devices; Classification of the Clitoral Engorgement Device

The Food and Drug Administration (FDA) is classifying the clitoral engorgement device into class II (special controls). The special control that will apply is a guidance document entitled: "Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997. The agency is classifying the clitoral engorgement device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.