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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.