Federal Register :: Public Inspection: Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format

Federal Register :: Public Inspection: Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format

Medical Device Submissions move to Electronic Format to Improve Program Efficiency

Today, 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.  We are taking this action to improve the efficiency of FDA’s premarket submission program for medical devices. Comments to this proposed rule should be submitted either electronically or in writing within 90 days after publishing in the Federal Register under docket number FDA-2018-N-0628. If you have any questions, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100. Thank you. Center for Devices and Radiological Health Food and Drug Administration