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In Reply to Parent Post by robert.beck
I have a related question. Normally, we generate a detailed DHF for all devices, but now we're starting make accessories which are quite a bit simpler than our previous devices. how far to we have to go with the DHF? we have a five-phase design and development process with lots of required documents, but for these simpler devices the process is seen as overkill.
looking through FDA's documents, I don't see much support for a two-tiered approach? any ideas?
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Look at the accessory's classification first. Some accessories will come under a dedicated classification, which may provide some exemptions relative to the parent device. Otherwise the accessory will come under the parent's classification. In the latter case, look for any specifics in that classification, that may provide a reduced burden. If none are there, you'd probably have to apply the whole lot. If the accessories are indeed simpler, then maybe you won't be able to skip any steps but the steps themselves will be easier.
Cheers,
Ronen.
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