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 Humanitarian Device Exemption HDE Program 2023-2024

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Instructions and help about Humanitarian Device Exemption HDE Program

foreign hi everybody this is Rob Packard from medical device Academy today's um and I'm out of focus sorry about that there we go uh today's video is going to be about what is a Class one and Class 2 device exemption next week we're going to talk about regulatory pathway in a blog that's related but this one's about exempt products so these are products that are going to be marketed in the US they're medical devices but they don't require some sort of regulatory clearance or approval by the FDA we're also going to talk a little bit about other types of exemptions for medical devices but we're going to start with the regulatory approval process so for those of you that aren't familiar with the difference be why I'm using the air quotes here the FDA only approves class 3 devices that require pre-market approval these are the highest risk devices Class 2 devices require pre-market notification you're notifying the FDA of your intent to market the product in the U.S but you have to first d

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