Send and Track Medical Device Premarket Submissions Online: CDRH Portal
CDRH Portal Updates
May 22, 2023 - The U.S. Food and Drug Administration (FDA) updated the CDRH Portal to allow users to track the progress of Pre-Submissions.
A submitter must specify the type of Pre-Submission request, which include:
- written feedback (only)
- written feedback followed by a meeting
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.
Starting 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.
Before October 1, 2023, you may submit 510(k)s by mail or through the CDRH Portal in either the eSTAR or eCopy format. The eSTAR is free and available for voluntary use by all medical device applicants wishing to submit 510(k)s and De Novo requests to CDRH. During the transition time up to the point when 510(k) electronic submissions will be required, anyone can voluntarily use eSTAR for 510(k) submissions. De Novo requests submitted using eSTAR remain voluntary until further notice.
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 or 510(k) submission (traditional, special, and abbreviated 510(k)s) 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 and 510(k) submissions, the FDA also formally notifies you of your submission's status by emailing your official correspondent with official actions and requests.
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.
For more information:
- Voluntary eSTAR Program
- eCopy Program for Medical Device Submissions
- How to Study and Market Your Device
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).
Questions?
If you have questions about the CDRH Customer Collaboration Portal ("CDRH Portal"), email ccp@fda.hhs.gov.