FDA Issues Final Rule on Electronic Data Submissions

The FDA published a final rule amending requirements for premarket submissions to remove paper and multiple copies and replace them with a single electronic submission format.

The action would reduce the number of copies in electronic format required and make the FDA’s premarket submission program for devices more efficient, the agency said.

The rule applies to all submission types. The agency said that electronic format includes eCopies, eSubmissions, and submissions created and submitted on CD, DVD or flash drive and mailed to the FDA.