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# Electronic Format Transparency Needed: Comment
- URL: https://www.fdaweb.com/electronic-format-transparency-needed-comment/
- Published: 2019-12-03T12:00:00.000Z
- Updated: 2026-09-14T15:55:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145639

AdvaMed says FDA should “adopt a practice of full transparency regarding its plans for submissions by electronic format.” In comments to an agency draft guidance on providing regulatory submissions for medical devices in electronic format, the association [says](https://www.regulations.gov/document?D=FDA-2019-D-3769-0007&ref=fdaweb.com) that information technology systems are complex and costly, and new systems require validations to be completed and new procedures and processes to be created. It notes that such activities are labor- and time-intensive and costly.

“The better industry understands FDA’s vision and expectations, the smoother the transition will be, benefiting all stakeholders,” AdvaMed writes.

The comment letter also recommends that in developing electronic format standards, FDA provide as much flexibility as possible.

In its [letter](https://www.regulations.gov/document?D=FDA-2019-D-3769-0006&ref=fdaweb.com), RTI surgical provided line-by-line technical comments.