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FDA Issues Policy For Making Immediate Changes To Device Submission Guidelines

CDRH has posted a final standard operating procedure to describe how it will rapidly inform stakeholders of changes to expectations for new device submissions in the form of “Level 1, Immediately-in-Effect” guidance documents.

FDA’s device center has finalized a new process for quickly disseminating updated guidelines for data expected in new product submissions.

The standard operating procedure document, posted on FDA’s website on March 25, describes CDRH’s “process to clarify and more quickly inform stakeholders when CDRH has changed its expectations...

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