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Send Medical Device eCopy and eSTAR Premarket Submissions Online

The U.S. Food and Drug Administration (FDA) is announcing that you may now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal (“CDRH Portal”).

“This announcement is a significant step forward in the FDA’s commitment to digital transformation. While the FDA’s broader modernization effort began in September 2019, the COVID-19 public health emergency and ongoing industry input sharpened our focus on transforming technology and processes to better serve all stakeholders. The CDRH Portal marks a significant step forward in CDRH’s commitment to using technology to increase efficiency, transparency, and simplicity in the submission and review process for medical device premarket submissions. With the CDRH Portal, manufacturers of devices can now quickly upload eSTAR and eCopy submissions and continue to track the progress of 510(k) submissions on a secure website.” — Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health  

Building on the progress tracker for 510(k) submissions launched in 2021 and the trial process of electronic uploads launched in July 2022, the CDRH Portal now allows anyone to register for a CDRH Portal account to send CDRH eCopy or eSTAR premarket submissions online.

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

*As noted in the final guidance, Electronic Submission Template for Medical Device 510(k) Submissions, 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.

The eSTAR is available for voluntary use by all medical device applicants wishing to submit 510(k)s and De Novo classification requests to CDRH. De Novo requests submitted using eSTAR remain voluntary until further notice.

Questions?

If you have questions, email ccp@fda.hhs.gov.