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US FDA finalizes Safety and Performance 510(k) registration route

FDA’s final guidance on what the agency calls its Safety and Performance Pathway is based on the Abbreviated 510(k) Program; FDA first announced plans to expand the Abbreviated 510(k) Program and published draft guidance in early 2018. Through this market authorization pathway, qualifying device manufacturers would be able to utilize performance criteria identified and approved by FDA to demonstrate Substantial Equivalence.

As per the guidance, Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding off substantial equivalence based on data showing the new device meets the level of performance of appropriate predicate device(s). The Safety and Performance Pathway approach to substantial equivalence stems from FDA’s Abbreviated 510(k) Program, wherein applicants demonstrate conformity to agency-recognized consensus standards, regulatory guidance or special controls in order to support their substantial equivalence claims.

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