Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation; Republication

The Food and Drug Administration (FDA) is republishing in its entirety a final order entitled "Medical Devices; Gastroenterology- Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation" that published in the Federal Register on May 28, 2015 (80 FR 30353). FDA is republishing to correct an inadvertent omission of information. FDA is classifying the vibrator for climax control of premature ejaculation into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the vibrator for climax control of premature ejaculation. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.