FDA Instructions for e-copies of submissions

The link provided contains instructions for those who would like to reduce the number of paper copies provided for submissions. An electronic copy can be provided in place of one of the paper copies of a submission. This eliminates the need for FDA to image the paper copies for internal use. Note that an electronic copy is not a full electronic submission. Also note that there are some specific folder naming conventions that must be followed or the e-copy will be rejected.

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just 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, TX) and Canada.