FDA proposes medical device submissions move to electronic format to improve efficiency

The U.S. Food and Drug Administration (FDA) published a proposed rule titled “Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format.”

The proposed rule requires medical device premarket submissions to be sent in electronic format, eliminating the need for multiple paper submissions. The FDA is taking this action to improve the efficiency of FDA’s premarket submission program for medical devices.

Comments to this proposed rule should be submitted within 90 days after publishing in the Federal Register under docket number FDA-2018-N-0628.