On 22 September, FDA issued the Electronic Submission Template for Medical Device 510(k) Submissions, a document that provides specifications on electronic 510(k) submission procedures to improve consistency of submission and efficiency of the review process.
The document complements last year’s previous version by providing additional standards for online submission and criteria for waivers and exemptions from requirements. The guidance document, “Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act” provides a process for developing templates to facilitate the preparation, submission, and review of applications for Medical Devices in electronic format only. FDA intends to implement the 754A(b)(3) requirements of the FD&C Act with individual guidelines that specifies formats for individual applications and deadlines for implementation.
In February 2020, the CDRH (Center for Devices and Radiological Health), in support of the transition to electronic 510(k) submissions, developed and launched the eSTAR (electronic Submission Template And Resource) pilot programme, a service that has been available since June 2022. The eSTAR template has similar features to the previous eSubmitter.
In contrast to eSubmitter, the eSTAR format has several advantages including the use of highly usable software that does not require special training, together with more dynamic features such as support for images and messages with hyperlinks, support for editing, mobile devices compatibility and the possibility for users to add comments to PDF documents. In addition, eSTAR content fully reflects the internal templates used by reviewers, thus favouring completeness of submission content and facilitating more efficient reviewing.
With the following summary, we would like to remind you that:
- Before 1 October 2023, 510(k) can be submitted by mail or through the CDRH portal in eSTAR or eCopy
- Starting 1 October 2023, all 510(k) applications, unless exempted*, must be submitted electronically using eSTAR.
- FDA has identified 1 October 2023 as the date on which it will require 510(k) submissions to be submitted electronically. FDA intends to accept 510(k) submissions saved to an electronic storage media and sent to the FDA by mail if they are received by the FDA before 1 October 2023.
*As outlined in the final guidance, Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and FDA Staff all 510(k) applications, including original 510(k) traditional, special, and abbreviated 510(k) applications and subsequent supplements and amendments, and any subsequent application to an original application, unless exempted in Section VI.A Waivers and Exemptions From Electronic Submission Requirements of the guidance, must be submitted electronically. The electronic submission template, eSTAR, is the only electronic submission template currently available to facilitate the preparation of electronic 510(k) applications.
Waivers and Exemptions
All 510(k) applications, including traditional, special and abbreviated applications and subsequent supplements and amendments, unless exempted by Section VI.A of the FDA document, must be submitted electronically. A 510(k) application not submitted electronically will not be received unless an exemption applies. In fact, electronic 510(k) submission requirements are exempt:
- Interactive review responses;
- Appeals/requests for revision;
- Substantive Summary Requests;
- Changes to corresponding amendments;
- Changes subsequent to final decision.
Given the wide availability of software to use the current PDF 510(k) eSTAR, FDA has not currently identified any special circumstances that would justify an exemption from the 510(k) electronic submission requirements and does not intend to entertain any waiver requests.
FDA has identified 1 October 2023 as the effective date for the requirements for electronic submission of 510(k) applications via portal. This date includes a transition period of at least one year. 510(k) applications saved to an electronic storage media and sent to FDA will only be accepted if received before 1 October 2023.
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