Docs of the Month: New Open Payment Specs, Alternative 510(k) Path

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CMS has rolled out new resources to support oncoming additions to the Open Payments disclosure database, and FDA has formally adopted the first two devices into its new, alternative 510(k) pathway—in August's Market Pathways’ “Docs of the Month.”

In our “Docs of the Month” series, we spotlight key items from Pathways’ Document Depot—our running, global inventory of medtech regulatory and policy documents. In this edition: new technical releases for an expanding CMS-administered Open Payments database and two final guidances from FDA that usher in its new 510(k) Safety and Performance Based Pathway.

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