Webinar – CDRH’s New Draft Guidances to Continue to Modernize the 510(k) Program
Summary
On October 26, 2023, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers and other stakeholders to describe the FDA’s ongoing efforts to modernize the premarket notification [510(k)] Program, and to provide an overview of three new draft guidances that the FDA believes will enhance the predictability, consistency, and transparency of 510(k) review. These draft guidances focus on best practices for selecting a predicate device, recommendations for when clinical data may be necessary in a 510(k) submission, and evidentiary expectations for 510(k) implant device submissions. The FDA will describe the ongoing efforts to modernize the 510(k) Program that led to these new draft guidances, provide an overview of the draft guidances, and respond to questions.
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