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FDA Emphasizes Timesavers In New eCopy Guidance

CDRH has again updated its eCopy guidance to highlight tools that the device center believes will speed up the premarket submissions and review process. The new document clarifies how the center wants sponsors to submit PDF files, spotlights a submission validation tool and includes other tips to reduce unnecessary eCopy holds that can delay submissions, a center official tells "The Gray Sheet."

FDA's device center wants sponsors to follow good etiquette when submitting submissions through their eCopy program. Specifically, the agency wants PDFs submitted through the system to be formatted properly to prevent unnecessary delays when reviewers work with them.

On Dec. 3, CDRH released an updated guidance for industry on its electronic copy (eCopy) program for medical device submissions based on

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