CDRH Initiatives Underway: Submission Withdrawals, Early Interaction, Refuse-To-Accept
This article was originally published in The Gray Sheet
Executive Summary
Initiatives to understand what factors drive sponsors to withdraw premarket submissions during review, to find the best ways of informally engaging with sponsors soon after submission and to clarify the 510(k) refuse-to-accept program are among steps highlighted by the device center in its plan to implement recommendations from a third-party assessment.
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