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US FDA Emphasizes Timesavers In New eCopy Guidance For Medical Devices

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration's medical device center has again updated its electronic copy (eCopy) guidance for industry to highlight tools that it believes will speed up the premarket submissions and review process1. The new document, published on Dec. 3, 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.

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