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

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:

The most significant changes appear to be to "The Special 510(k) Program," which replaces the 28 September 2018 draft guidance of the same name. Clarifying language in the Special 510(k) final guidance underscores the agency's shift in focus for what types of submissions are eligible for the program. Criteria for acceptance for review of changes to previously cleared devices through a Special 510(k) notice will focus on whether methods to evaluate the changes are well established and whether results can be sufficiently reviewed in a summary or risk analysis format. The final guidance also indicates that in the case of in vitro diagnostics (IVDs), the need for clinical data to evaluate changes will not necessarily be a bar to acceptance to the program.

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


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