eCopy Program for Medical Device Submissions


Certain medical devices must provide an electronic copy (eCopy) of their submission.   An eCopy is a duplicate of the paper copy that is submitted to the FDA, and may be submitted on a CD, DVD, or flash drive.  The purpose of an eCopy is to improve the review process by making a submission available immediately.  The updated guidance document “eCopy Program for Medical Device Submissions” was … Read More

CDRH Releases New Strategic Priorities for 2014

OMEDtechNews & Events

The CDRH has released their new strategic priorities for 2014.  They will focus on three different areas of improvement with specific goals and deadlines for each area.  Their overall goal is for patients to have access to safe and effective medical devices as soon as possible.  To accomplish this goal they are looking to make improvements that would encourage medical … Read More