> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CDRH Modifies Electronic 510(k) Portal
- URL: https://www.fdaweb.com/cdrh-modifies-electronic-510-k-portal/
- Published: 2023-03-20T12:00:00.000Z
- Updated: 2026-09-14T18:20:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154014

CDRH is adding [more functionality](https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal?utm%5Fmedium=email&utm%5Fsource=govdelivery) to its medical device electronic submission portal to prepare for an all-electronic submission process. Beginning 10/1, all 510(k) submissions including original submissions for Traditional, Special, and Abbreviated 510(k)s, and subsequent supplements and amendments will be required to be submitted in (XXX SUBSTITUTE XXX) XXX)electronic form. The agency has released the final guidance, [Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and FDA Staff](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-510k-submissions?ref=fdaweb.com) to assist sponsors. The new enhancements to the portal are:

- •Allowing more company users to view the status of 510(k) submissions. The update allows the official correspondent to specify one or more delegates who can view the status.
- Allowing users to filter and sort the list of submissions to make it easier to see their information.
- Permitting users to access the new CDRH Portal Help section to read common questions and learn about new features.