FDA finalises guidance on electronic 510(k) submissions

Electronic submissions to be required by October 2023

The FDA launched a pilot programme for electronic premarket submissions to demonstrate that the device to be marketed is substantially equivalent to a legally marketed device, known as 510(k) submissions. This was known as the eSubmitter electronic submission template. This pilot programme ended in May 2021. In September 2021, a draft guidance document ‘Electronic Submission Template for Medical Device 510(k) Submissions’ was issued to provide a process to help prepare, submit and review regulatory submissions in an electronic format. September 2022 saw the publication of the finalised guidance document. The guidance provides:

• Further standards for the submission of 510(k) submissions by electronic format,
• A timetable for establishment of these standards, and
• Criteria for waivers of, and exemptions from, the requirements to meet a statutory requirement. 

The electronic submission template is known as eSTAR. This is a collection of questions, text and prompts within a template that guides the user through construction of a 510(k) submission. The eSTAR template is highly automated. It is integrated with FDA databases, such as for product code and recognised standards. eSTAR also:

• Includes questions to collect specific data and information,
• Provides links to applicable regulations, guidance documents and other reference resources
• Assembles the submission to closely follow the content of the template used by CDRH reviewers

Submissions made on eSTAR are not expected to go through a refusal to accept review, as the template will state if the information is complete.  The submission will undergo a virus- screening scan and a technical screening process. The technical screening process is intended to verify that the eSTAR responses accurately describe the device(s) and that there is at least one relevant attachment for each each applicable question requiring an attachment. This screening process will be performed within 15 days of FDA receiving the 510(k) eSTAR and once the appropriate user fee has been paid. If the eSTAR template is not complete, the submitter will be notified by email, the incomplete information identified and the 510(k) placed and remain on hold until a complete replacement is submitted. For a submission that passes technical screening, the review clock starts on the day the submission was received by the FDA. 

Currently the eSTAR process is voluntary but will become mandatory starting from 1 October 2023. It is not to be used for combination products. Although eSTAR is free to use, the standard submission fees for 510(k) submissions apply. 

Manufacturers making 510(k) submissions in the USA shall be aware of this guidance and October 2023 deadline for its mandatory use. Manufactures with 510(k) submissions in preparation should consider switching to the eSTAR template during the period of its voluntary use to gain experience and be prepared for its mandatory use.