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It’s Raining Guidance Docs: FDA Expands Abbreviated 510(k) Program

In a new final guidance, the US agency has expanded its abbreviated 510(k) program for certain devices to look beyond conformity assessments and instead look at performance criteria. Alongside the guidance, the agency also released four draft guidances for devices it is considering clearing under the new pathway.

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The US food and Drug Administration has published a major final guidance that seeks to further expand its abbreviated 510(k) program. Alongside the guidance, regulators have also proposed corresponding draft guidances that would guide the types of medical devices that could be reviewed under the expanded program.

The agency released the guidances on 19 September, only a week after it published four updated guidance docs 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 when the FDA would issue refuse-to-accept letters for 510(k) submissions

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