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# Changes for Electronic Submission Guidance
- URL: https://www.fdaweb.com/changes-for-electronic-submission-guidance/
- Published: 2021-11-16T12:00:00.000Z
- Updated: 2026-09-14T17:22:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150580

Cook Group says the FDA non-in vitro diagnostic electronic submission template and resource (eSTAR) is easy to use and intuitive, while also driving standardization. In an 11/12 comment letter on an agency draft guidance on the electronic submission template for medical device 510(k) submissions, Cook [says](https://downloads.regulations.gov/FDA-2021-D-0872-0007/attachment%5F1.pdf?ref=fdaweb.com) additional clarification would be beneficial. It recommends: 

- clarifying or adjusting the eSTAR process so it can be used as an effective submission archive;
- shortening the technical screening process from 15 days to 3-5 business days;
- updating the eSTAR template to enable the summary of additional biocompatibility testing when needed to demonstrate substantial equivalence to predicate devices regardless of type and duration of material contact; and
- ensuring CDRH reviewers receive adequate training on the electronic submission template.

Cook also urges FDA to develop specific timeframes for all the tasks that remain to be done to meet requirements in the law and apply the necessary resources to complete them in the next few years.