https://www.federalregister.gov/documents/2019/12/16/2019-27047/medical-device-submissions-amending-premarket-regulations-that-require-multiple-copies-and-specify?utm_campaign=2019-12-13%20Final%20Rule%20Submissions%20Electronic%20Format&utm_medium=email&utm_source=Eloqua

FDA issues a Final Rule to Require Medical Device Submissions in Electronic Format

Today, the U.S. Food and Drug Administration (FDA) issued a final rule, Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Required in Electronic Format. The new 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. Read the Final Rule

The FDA is also publishing a revised eCopy Guidance “eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff.”  The update to the eCopy guidance reflects the amendments to the regulations. Additional Guidances Several additional guidances are being updated to conform to changes made in the final rule: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Real-Time Premarket Approval Application (PMA) Supplements 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes Annual Reports for Approved Premarket Approval Applications (PMA) FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act Questions? If you have any questions, contact the Division of Industry and Consumer Education (DICE).