On August 5th, the US Food and Drug Administration (FDA) released a new guidance on 510(k) submissions. This guidance is called “Refuse to Accept Policy for 510(k)s” and the plan is for it to be in effect this October.
The reason for this new guidance is to provide more of a consistent acceptance amongst 510(k) submissions. The new changes include checklists, criteria for submission, as well as criteria for alternate submissions. FDA hopes the new guidance will help make submissions smooth to submit and accept in the future.