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Send and Track Medical Device Premarket Submissions Online: CDRH Portal

Update: December 18, 2023

The U.S. Food and Drug Administration (FDA) updated CDRH’s Customer Collaboration Portal (CDRH Portal) to help users track the progress of their De Novo classification requests.

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 any tracked submissions that are shared with a user.
  • 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. 

All CDRH-led premarket submission types may be uploaded to the CDRH Portal at any stage of the review process. Official correspondents do not need to send a physical cover letter to the FDA after uploading an electronic submission to the CDRH Portal. Please note that the CDRH Portal cannot receive submission files larger than 4GB or PDF files with attachments larger than 1GB.

CDRH's Customer Collaboration Portal ("CDRH Portal")

Send a Medical Device eSTAR or eCopy Premarket Submission Online

Anyone can register for an account in the CDRH Portal and send CDRH eSTAR or eCopy premarket submissions online.

As of October 1, 2023, all 510(k) submissions, unless exempted*, must be submitted as electronic submissions using eSTAR.

Send your Premarket Submissions Online

*As noted in the final guidance, Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and FDA Staff, all 510(k) submissions including original submissions for Traditional, Special, and Abbreviated 510(k)s, and subsequent Supplements and Amendments and any other subsequent submissions to an original submission, unless exempted in Section VI.A Waivers and Exemptions From Electronic Submission Requirements of the guidance, are required to be submitted as electronic submissions. The electronic submission template, eSTAR, is the only currently available electronic submission template to facilitate the preparation of 510(k) electronic submissions.

To ensure your submission is processed, please submit your complete response to additional information (AI) requests through the CDRH Portal by 4 PM ET on the due date.  If your response is not received by the deadline, it will be considered withdrawn, and we will delete it from our review system.

Submissions received before 4 PM ET on a business day (Monday through Friday excluding U.S. federal holidays) will be processed the same day. If received after 4PM ET, the submission will be processed the next business day.

If mailing a premarket submission, please send it to CDRH's Document Control Center (DCC):

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Progress Tracker for Premarket Submissions

The online progress tracker has a dashboard that displays near real-time submission status. The FDA secures the information about each submission's progress to ensure only the official correspondent or designated delegates for that submission can view the status.

When you send a CDRH Pre-Submission, 510(k) submission (traditional, special, and abbreviated 510(k)s), or De Novo classification for review, your official correspondent or designated delegates can monitor the FDA's progress online in a simple, concise format.

The official correspondent for an eSTAR submission is the person identified in the:

  • "Contact" section, or as the
  • "Primary Correspondent/ Consultant," if applicable.

The official correspondent for an eCopy submission is the person identified in:

  • Section C of CDRH Premarket Review Submission Cover Sheet (Form FDA 3514) or in
  • Section B (if Section C is blank on the Cover Sheet form), or in the
  • Cover letter, if the eCopy submission does not include a Cover Sheet form.

What to expect:

  • If this is your official correspondent's first time tracking a submission online, the FDA automatically emails a link to create a login password soon after the FDA starts its review.
  • While the CDRH Portal features online progress tracking for Pre-Submissions, 510(k) submissions, and De Novo classification requests, the FDA also formally notifies you of your submission's status by emailing your official correspondent with official actions and requests.

Track Your Submissions

Technical Limitations

The CDRH Portal cannot receive files that are: 

  • larger than 4GB, or 
  • PDFs with an attachment larger than 1GB.

To submit electronic files that exceed the technical limitations, you can mail the electronic version of your submission to the CDRH Document Control Center (DCC) at this address:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

For more information on mailing submissions, please read eCopy Medical Device Submissions

Next Steps

The FDA will maintain and improve on the Customer Collaboration Portal ("CDRH Portal") as described in the Draft: Medical Device User Fee Amendments (MDUFA) Performance Goals and Procedures, Fiscal Years 2023 through 2027.

CDRH Portal chart of text described in MDUFA letter. It has a flowchart of the CDRH Portal. The first flow shows the Progress Track which currently tracks De Novo, 510(k) and PreSub submissions. The second flow shows the Voluntary submissions which are divided in two tracks: (1)eCopy submissions, PMA, De novo, Q-Sub, IDE, HDE, etc., and the second flows shows the eSTAR submissions  De Novo and PreSub and PMA.

For more information:

* When final, this guidance will represent FDA’s policy on this topic.

NOTE: Only CDRH submissions may be sent through the CDRH Portal. For biologic products or devices used in blood establishments, please submit to the Center for Biologics, Evaluation, and Research (CBER).


If you have questions about the CDRH Customer Collaboration Portal ("CDRH Portal"), email ccp@fda.hhs.gov.


CDRH Premarket Online

Updates for the medical device industry on CDRH’s efforts to make more premarket activities available online.

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