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User fees: 3rd-party and EU CAB (conformity assessment body) reviewed-devices need not pay

This article was originally published in Clinica

Executive Summary

The US FDA offers both good and bad news in a new guidance document discussing the less obvious examples of when it will assess a user fee and when it will not. On the positive side, user fees will not be charged if the device is submitted by a state or government official, is solely intended for children, or when the 510(k) has already been reviewed by a US third party or an EU conformity assessment body, it said.

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