FDA Issues Draft Guidance on Providing Regulatory Submissions in Electronic Format

Today, the U.S. Food and Drug Administration (FDA) issued draft guidance, Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.

This guidance discusses:

• submission types that will be required to be submitted solely in electronic format as required by section 745A(b) of the Federal Food, Drug, and Cosmetic Act,
• a timetable and process for implementing the requirements,
• criteria for waivers of and exemptions from the requirements for electronic submissions, and
• a process to periodically issue guidance relating to the submission in electronic format for certain submission types.

The draft guidance is open for public comment for 60 days at www.Regulations.gov under docket number FDA-2019-D-3769.
Submit Comments  & Questions?

If you have questions about this draft guidance, contact the Division of Industry and Consumer Education (DICE) or you can contact the Regulatory Support Team at Lean Enterprise Consulting, www.lec.guru


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