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# Electronic Submission of eSTAR 510(k)s Needed: Consultant
- URL: https://www.fdaweb.com/electronic-submission-of-estar-510-k-s-needed-consultant/
- Published: 2021-11-09T12:00:00.000Z
- Updated: 2026-09-14T17:21:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150539

Medical device regulatory consultant **Adrienne Lenz** (Hyman, Phelps & McNamara) says FDA needs to catch up with technology so that 510(k) submissions created with the eSTAR (electronic submission template and resource) template can be submitted to the agency electronically. Writing in her firm’s *FDA Law Blog*, Lenz [says](https://www.thefdalawblog.com/2021/11/submitting-a-510k-keep-hoarding-blank-cds/?ref=fdaweb.com) a 9/29 agency draft guidance gives FDA’s interpretation of the FDA Reauthorization Act requirement for submission in electronic format.

She writes she was surprised that although the guidance defines an eSubmission as “a submission package produced by an electronic submission template that contains the data of a complete submission,” it does not also entail the electronic transmission of the 510(k) files to the agency.

“The guidance explains that, when final, 510(k)s would need to be provided as an electronic submission prepared with the current eSTAR template,” Lenz writes. “It does not appear that changes to the eSTAR template are proposed at this time.”