FDA releases four final guidances on the 510(k) program; Special 510(k) guidance confirms new approach to eligibility and broader potential for IVDs

Kristin Zielinski Duggan, Lina Kontos
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On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program.

Please see full publication below for more information.

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