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FDA Scheduled Updates for the CDRH Customer Collaboration Portal Including New Features (and Penguins)
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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.
New Features:
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.
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You can now tell which submissions in the tracking section have been shared with you
With the ability to share the progress tracking of a submission in the Portal with other team members (see the Portal help > Common questions section to learn more about that feature) some confusion was caused for folks as it was not clear which submissions were “theirs” (they are the Official Correspondent) and which had been shared with them. All submissions for which the progress tracking has been shared with you will now display an icon indicating their shared status.
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Penguins?
Bjorg the penguin has existed in the Portal since the beginning. However, he has become upset that you all don’t get to see him unless things have departed from an optimal path. So he has snuck into other parts of the CDRH Portal; If you look around in Portal help articles, you may just spot him in one of his poses.
As always, once you log in to the Portal, you can visit Portal Help (the ? icon found in the lower left corner of the Portal) “What’s new?” section to find out what was added in each release and to find answers to the most common questions.
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We hope that you find the CDRH Portal to be useful and user friendly. If you have questions not covered in Portal Help or have feedback on the Portal, please reach out to ccp@fda.hhs.gov.
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Starting your journey towards meeting with the FDA regulatory requirements? Let Celegence assist you. Reach out to us today to explore the possibilities of partnering with Celegence’s regulatory team. For more information reach out to us at info@celegence.com, contact us online or learn more about our service offering on our services page.
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