On October 2, 2023, the FDA  published an update to the Electronic Submission Template for Medical Device 510(k) Submissions guidance: Guidance for Industry and FDA Staff since as of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted using the eSTAR portal (electronic Submission Template And Resource).

 

Applicants must implement the requirements of Section 745A(b)(B) of the FD&C Act which require that all 510(k) submissions – traditional, special and abbreviated – and subsequent supplements or amendments, unless exempt under Section VI, must be submitted through eSTAR.

The guideline in Table 1 gives a high-level overview of the structure of the current electronic submission template for 510(k) files and a summary of the expected content of the submission.

The eSTAR format, compared to its predecessor eSubmitter, has several advantages including an easy-to-use software that does not require special training, more dynamic functions such as support for images and messages with hyperlinks, compatibility with mobile devices and the possibility for users to add comments to PDF documents. In addition, the content of eSTAR fully reflects the internal templates used by reviewers, thus favouring the completeness of the content of the presentation and facilitating its review.

FDA therefore identified October 1, 2023 as the effective date for the requirements for electronic submission of 510(k) applications via the eSTAR portal.

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Source:

Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and FDA Staff