Gastroenterology-urology devices; classification for external penile rigidity devices. Final rule.
The Food and Drug Administration (FDA) is classifying external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II (special controls). FDA also is exempting these devices from premarket notification requirements. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the device.
D004867:Equipment Design; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D008297:Male; D015917:Penile Prosthesis / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration