Updated eCopy Guidance Clarifies FDA’s Electronic Submission Program
This article was originally published in The Gray Sheet
Executive Summary
According to an updated guidance on FDA’s eCopy submission program, it now accepts a broader range of PDFs. The update contains expanded guidelines for industry when submitting electronic versions of applications to FDA.
You may also be interested in...
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."
TurboTax For 510(k)s? FDA Seeks Volunteers For eSubmissions Pilot
The agency has launched a pilot that will allow makers of cardiac diagnostic and peripheral interventional devices to submit 510(k)s in electronic-only format. FDA says it expects the program to improve both speed and quality of submissions.
TurboTax For 510(k)s? FDA Seeks Volunteers For eSubmissions Pilot
The agency has launched a pilot that will allow makers of cardiac diagnostic and peripheral interventional devices to submit 510(k)s in electronic-only format. FDA says it expects the program to improve both speed and quality of submissions.