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Wave Of Overhauled FDA 510(k) Guidance Documents Aims To Streamline Reviews

Executive Summary

The US agency has released four updated guidance documents aimed at providing more clarity on how it intends to review 510(k) applications. The FDA says the guidances are intended to reduce unnecessary burdens for its review staff and to help sponsors avoid wasting resources. We break down each of the docs and explain what your company needs to know.

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