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Would not have guessed this was a medical device
I just learned that personal lubricants are classified by the FDA as a medical device.
Who knew? -
5 Replies
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That definition is…excruciatingly in depth and specific.
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Have made many, never knew.
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Yes, the FDA really focused on personal lubricants over the past year, so these are relatively new regulations. Basically, a personal lubricant now has to meet the same criteria as lubricants used on lubricated condoms. So, quite a few products had to be pulled from store shelves until they passed the required testing. As if the government didn’t have more important things to take of.
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I used to make a spray fixative for microscope slides for a company. I think it was sold to gynecologists offices. Turns out this was a medical device too.
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I have a question kind of regarding this. Would creams, washes, or masks that are sold to be use in the genital area be considered a medical device? Also would something sold to treat ingrown hairs need to labeled and tested as a cosmeceutical?
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