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[FDA Regulatory] As of October 1, 2023, all FDA 510(k) submissions are mandatory through eSTAR.

fda 510(k) estar

On October 2nd, the U.S. Food and Drug Administration (FDA) issued final guidance on the "Electronic Submissions Template for Medical Devices 510(k) Submission." This guidance contains information about the use of the Electronic Submission Template and Resource (eSTAR) through the CDRH portal.

As of October 1, 2023, all medical device FDA 510(k) submissions must be made through eSTAR without any exemptions.

This final guidance provides the following minor updates:

  • Withdrawal requests, which have previously been submitted via email continue to be exempt from electronic submission requirements.

  • While eSTAR will be required starting on October 1, 2023, there are currently known technical reasons that preclude electronic submission via the CDRH Portal and impacted submissions must be mailed to the CDRH Document Control Center.

eSTAR is intended to enhance the incoming quality of submissions for a wide range of medical devices. Its main objective is to assist submitters in providing high-quality and comprehensive data for premarket reviews.

By using the standardized template, submitters can ensure that all necessary information is fully prepared and submitted during the review process. This allows the FDA to conduct premarket reviews more efficiently, promoting timely access to safe, effective, and high-quality medical devices.

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