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# Draft Guide on Device e-Submissions
- URL: https://www.fdaweb.com/draft-guide-on-device-e-submissions/
- Published: 2019-09-26T12:00:00.000Z
- Updated: 2026-09-15T01:52:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145100

*Federal Register* notice: FDA has made available a draft guidance entitled “Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.” Agency regulations require that certain presubmissions and submissions for devices be submitted in electronic format specified by FDA. The guidance provides standards for the submission by electronic format, a timetable for establishment of the standards, and criteria for waivers of and exemptions from the requirements. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-09-26/pdf/2019-20949.pdf?ref=fdaweb.com).