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Reusable Menstrual Pads Classified as Medical Devices and Retailers Must Pay FDA Fee

Dec 15, 2014

Because the Food and Drug Administration  (FDA) classifies menstrual cups and reusable menstrual pads as “medical devices,” retailers are being required to pay a “premarket notification fee” to continue the sale of these products.

Reusable pads made from absorbent fabrics like cotton can be washed and reused. Menstrual cups fit inside the vagina and catch the menstrual flow. Many women choose such products as an environmentally friendly alternative to disposable pads and tampons, Medical Daily reports.

The FDA definition of a medical device is something “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,” or something “intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” Joint replacement devices and pacemakers are classified as medical devices, as are vaginal speculums and umbilical clamps. But sellers of menstrual products question why the products are classified as medical devices, and some are having trouble coming up with the fee.

For MotherMoonPads, a small company that sells reusable pads, the fee represents a significant portion of the company’s income, according to Medical Daily. Denelle Philemon said the pads are a safe choice for a woman’s menstrual needs and "[r]equiring cloth menstrual pad companies to register with the FDA will take away those choices” for many women.

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