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Bhargav replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices 7 years, 9 months ago
In 2016, the FDA issued a final deeming regulation that will regulate e-cigarettes as tobacco products, but the regulation, while addressing some key policy issues, still leaves significant regulatory gaps. In addition, the regulation will be phased in over the next few years, so even if it is not delayed as a result of litigation or other reasons, many requirements will not take effect until August 2019. I think that the e-cigarettes are considered a drug delivery system and should be classified as a class 3 medical device.