|
 
Today, the U.S. Food and Drug Administration (FDA) updated the CDRH’s Customer Collaboration Portal (CDRH Portal) to help users track the progress of their De Novo classification requests.
The latest portal updates are aimed at improving the user experience by providing additional information and more filters on the user’s home screen to facilitate the submission process.
What’s new in the portal:
- The option to display the device name and company name columns on the user’s home screen.
- An icon to indicate to an authorized recipient that a tracked submission has been shared with them by the official correspondent.
- The ability for a user to track their supported submission types during user fee holds and/or format holds for 510(k) originals, De Novo originals, Pre-Sub originals, and Pre-Sub supplements.
The CDRH Portal updates are a step forward in meeting the Medical Device User Fee Amendments 2022 (MDUFA V) commitments of using technology to enhance efficiency and transparency in reviewing industry submissions.
To learn more about De Novo requests, visit the De Novo Classification Request website.
Questions?
If you have questions about the CDRH Portal, email ccp@fda.hhs.gov.
|
|
|
|
