FDA 510 k Submission: A Step By Step Guide
510k premarket submission is not required when someone is selling an incomplete device to another firm for further completion. If the device is manufactured outside the country and you are importing it, then you don't need 510 premarket submissions if the foreign manufacturer of that device has already submitted it. Read http://demandingbizservices.over-blog.com/2020/07/fda-510-k-submission-a-step-by-step-guide.html
510k premarket submission is not required when someone is selling an incomplete device to another firm for further completion. If the device is manufactured outside the country and you are importing it, then you don't need 510 premarket submissions if the foreign manufacturer of that device has already submitted it. Read http://demandingbizservices.over-blog.com/2020/07/fda-510-k-submission-a-step-by-step-guide.html
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Requirement for 510 k submission
510 k submission is also required when there is an alteration and
change to a legally marketed device because that alteration or
modifications can impact its safety. 510 k premarket submission is
not required when someone is selling an incomplete device to
another firm for further completion. If the device is manufactured
outside the country and you are importing it, then you don't need
510 premarket submissions if the foreign manufacturer of that
device has already submitted it. The categorizing and submission
processes related to medical devices are very different from those
provided for pharma products. That's why it includes that 510 k
premarket notification.
Source: http://demandingbizservices.over-blog.com/2020/07/fda-
510-k-submission-a-step-by-step-guide.html
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