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Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File
Dear all:
I have another question: If the design change occurs during the 510(k) review process, do i have to notify the design change to FDA and submit the related materials to FDA, or i just have to keep silent and document the design change according to FDA's guidance document<Deciding when to submit new 510(k) for the existing device>
I prefer the later choice, because our device is changing very fast, and FDA's review time is very long for us. If i choose to submit the related material of design change to FDA, the review time will be enlarged with no limit and without stop.
However, i don't know if there is any regulation put any restrict on such behaviour, can you give me some commends?
Any commends will be appreciated.
Dear all:
I have another question: If the design change occurs during the 510(k) review process, do i have to notify the design change to FDA and submit the related materials to FDA, or i just have to keep silent and document the design change according to FDA's guidance document<Deciding when to submit new 510(k) for the existing device>
I prefer the later choice, because our device is changing very fast, and FDA's review time is very long for us. If i choose to submit the related material of design change to FDA, the review time will be enlarged with no limit and without stop.
However, i don't know if there is any regulation put any restrict on such behaviour, can you give me some commends?
Any commends will be appreciated.