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  • Josh started the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices 9 years, 2 months ago

    This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework.

    Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA currently regulate e-cigarettes?

    Here we have a situation where there is an electronic device that vaporizes water containing other organic compounds, so you can breathe in that vapor and deliver it to your lungs. Do you think that is different from a normal cigarette in terms of regulation?

    Why doesn’t the FDA regulate normal cigarettes?

    Do you think an e-cigarette should be a drug delivery device and therefore a Class III medical device that will require a full clinical trial for EACH MODEL released by EVERY company?

    Find some articles on the web about this. They are fun to read.