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

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.

Surfer-over-papers

The US Food and Drug Administration has released a slew of updated guidances revamping its 510(k) review pathway, aimed at streamlining its work while also intending to help sponsors save time and resources.

The four guidances – aimed at clarifying the agency's thinking on its Special and Abbreviated 510(k) Programs, and explaining how to format traditional and abbreviated 510(k) submissions, as well as...

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