FDA Electronic Copies of Submissions Instructions

FDA issued a Q&A of instructions for provision of electronic copies of premarket submission. Maximum individual file size is 50MB and the primary format is Adobe PDF but other data formats not requiring special viewers are acceptable. An electronic copy counts as one of the requried copies for a premarket submission. Full instructions are at the link provided.

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.