Zdrowie i gospodarka · 28/12/2004

FDA Classifies External Penile Rigidity Devices as Class II Medical Devices with Special Controls

The US Food and Drug Administration (FDA) has classified external penile rigidity devices, used to enhance sexual intercourse, as Class II medical devices requiring special controls, and exempted them from premarket notification requirements. The FDA has also made available a guidance document outlining the special control for these devices.