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US FDA Emphasizes Timesavers In New eCopy Guidance

This article was originally published in Clinica

Executive Summary

The US FDA's device center wants PDFs submitted through the system to be formatted properly to prevent unnecessary delays when reviewers work with them. With this aim in mind, on Dec. 3, the Center for Devices and Radiological Health released an updated guidance (PDF) for industry on its electronic copy (eCopy) program for medical device submissions based on recommendations from Booz Allen Hamilton as part of the contractor's ongoing independent review of FDA's procedures.

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