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  • reshamn replied to the topic Classification in FDA Vs EU in the forum EU Regulatory Basics 7 years, 8 months ago

    I was able to find one example of where the classification of a device was different in the EU vs the US. Contraceptives such as a female condom is classified as a Class III device in the US where as in the EU it is classified as Class II. This is surprising since there have been many petitions to classify female condoms as Class II, similar to the male condoms in the US. This unfair and unnecessary labeling variation makes it harder for manufacturers to get new types of female condoms approved for sale in the United States, and ultimately harms women’s health. Right now, women in the U.S. can only buy the FC2 female condom, but there are other types available internationally like in EU.