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 submission online.

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

Send your Premarket Submission(s) 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 510(k)s

The online progress tracker has a dashboard that displays near real-time submission status. The FDA secures the information about each submission's progress, so only the official correspondent for that 510(k) submission can view it.

When you send a CDRH 510(k) submission (traditional, special, and abbreviated 510(k)s) for review, your official correspondent 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 510(k) submissions, the FDA also formally notifies you of your 510(k) submission's status by emailing your official correspondent with official actions and requests.

Track Your 510(k) Submission(s)

Next Steps

The FDA will maintain and improve on the Customer Collaboration Portal as described in the Draft: Medical Device User Fee Amendments (MDUFA) Performance Goals and Procedures, Fiscal Years 2023 through 2027. The FDA intends to expand its tracking feature to other submission types and add other capabilities, such as secure communications, in 2023.

For more information:

• Voluntary eSTAR Program
  • Guidance: Electronic Submission Template for Medical Device 510(k) Submissions
• eCopy Program for Medical Device Submissions
  • Guidance: 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 [email protected].