What Is This Device?
An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.
What Is FDA Product Code HHD?
Pad, Menstrual, Unscented is FDA product code HHD, Class 1, 21 CFR 884.5435.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.