FDA wants to boost take-up of third-party reviews
This article was originally published in Clinica
The US FDA intends to expand the list of products that can participate in its third-party review programme, by early next year until at least 60% of all 510(k) submissions are eligible. Under the terms of the FDA Modernization Act, the third-party programme will end five years after the agency reaches that percentage, unless it is renewed by Congress.
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