On December 15, 2023, the FDA will begin the CDRH Portal (Customer Collaboration Portal) deployment in which new features will be added, adjusting the Christmas lights, and sweeping out the hearth.
The Portal deployment will run from 21:00 ET on Friday, December 15th to 02:00 ET Saturday, December 16th. While the Portal will be accessible and generally functional during this time, you may experience intermittent disruptions and we recommend you avoid uploading any submissions.
De Novo submissions will now be trackable!
After this release is live, the progress tracking functionality will include support for De Novo submissions in addition to the currently supported Pre-Submissions and 510(k) types. If you are the Official Correspondent of an active De Novo, you should see it on your Portal dashboard by Sunday December 17th. If you have questions about who qualifies as the “Official Correspondent” please see the related article in Portal Help > Common questions.
User Fee and Format Hold now supported in progress tracking for original submissions
You asked for it, and now it is here! You now will be able to track a supported submission when it is on user fee and/or format (usually eCopy) hold. Any 510(k)/De Novo original, or Pre-Sub original/supplement will display in the tracking section if it is on user fee hold and/or format hold. Previously submissions only appeared in the tracking section once they had been verified to have a valid format and user fee payment (when applicable).
New “Device Name” and “Company Name” optional columns added to the tracking table
You can now edit the columns that appear in the progress tracking section of the Portal home page, including temporarily adding both “Device Name” and “Company Name” columns. You will not be able to save that customized view, though we hope to add that functionality in a future release.