In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to modernize the 510(k) pathway.

The first of these is issuance of a final guidance entitled "Safety and Performance Based Pathway," which finalizes the 12 April 2018 draft guidance entitled "Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria." The second is solicitation of public comments on steps the agency can take to further enhance the safety of 510(k)-cleared devices.

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