If a vendor can prove that their product is a Substantial Equivalent to a previously-cleared device, (called a predicate device) then only a Pre Market Notification, or a 510(k) is needed.

For example: After the first mammography system was approved using a PMA, other vendors of these systems could file a SE claim in the form of a 510(k), and would not have to go through the lengthy PMA process which includes these costly clinical trials.

Topic

  • Standards

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