https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab?utm_campaign=2020-07-14%20Regulatory%20Submission%20Guidance&utm_medium=email&utm_source=Eloqua

FDA Issues Final Guidance on Providing Regulatory Submission in Electronic Format

Today, the U.S. Food and Drug Administration (FDA) issued final guidance: Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.

Read the Guidance The final guidance: Specifies which submissions will be required to be submitted solely in electronic format Provides criteria for waivers of the electronic submission requirements Provides criteria for submissions exempt from electronic format requirements Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.