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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510 k submission guideline
The submitter cannot market its devices until he receives the
approval, which declares that it is substantially equivalent. A
substantial equivalence requires consideration under 510 k
submission that they are equal to other legal devices in the market
approved. If FDA doesn't require the devices as substantially
equivalence, then the submitter has to resubmit the other 510 k
with all new data. If the FDA approved the device as a substantial
equivalent, it could be marketed across the country. The approval
is made within 90 days by the FDA, as it depends on the details
submitted by the submitter. The product can be marketed instantly
only after the approval by the FDA. 510 k submission is required
when a company introduces a new device into a market for the first
time.
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