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Once you get one device approved it's easier to get others approved under one of the new fast track programs (or at least that's what my FDA consultant told me
by tedivm 2y ago
Once you get one device approved it's easier to get others approved under one of the new fast track programs (or at least that's what my FDA consultant told me a couple of years ago, I'll admit I'm not personally an expert on this).
- not_the_fda 2y agoNot exactly. A novel device has a higher bar to get clearance. If you are developing something that already exists i.e. a hearing aid then you can go the 510k route. Every model has to go through the same rigor with design controls and get clearance through the 510k process. There is a lot of process and documentation, and as a medical device you can't just update firmware and swap components as they go end of life. And you can't just discontinue a product. When you submit for approval you have to define the lifetime of the product and how you plan to support it through that lifetime. I imagine Apple will keep the AirPods Pro 2 around for about a decade as their hearing aid device.