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# Medical Device Electronic Format Guidance
- URL: https://www.fdaweb.com/medical-device-electronic-format-guidance/
- Published: 2020-07-14T12:00:00.000Z
- Updated: 2026-09-14T16:21:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147184

FDA has published a guidance, *Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act*, to satisfy requirements in the law and the MDUFA 4 commitment letter to provide final guidance documents. “The agency has concluded that it is not feasible to describe and implement the electronic format(s) that would apply to all the submissions covered by Section 745A(b)(3) in one guidance document,” the [guidance](https://www.fda.gov/media/131064/download?ref=fdaweb.com) says.

Accordingly, the document describes how FDA interprets and plans to implement the requirements of section 745A(b)(3), while individual guidances will be developed to specify the formats for submissions and corresponding timetables for implementation.

Specifically, the guidance says, it discusses **(1)** the submission types that must be submitted electronically; **(2)** the timetable and process for implementing requirements; and **(3)** criteria for waivers of and exemptions from the submissions in electronic format requirements.