FDA New eCOPY for Medical Device Submissions

FDA issued “eCopy Program for Medical Device Submissions” guidance dated Dec. 3, 2015. This document is at the link provided and replaced the prior version dated Oct 10, 2013. Electronic copies are required for many types of submissions to FDA. Section 6 Table 1 indicates which submissions require ecopies and how many and which are voluntary. Attachment 1 provides technical standards for ecopies and they are organized PDFs and FDA encourages use of bookmarks and hyperlinks.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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