510(k) medical device submissions must be electronic by October 2023, FDA says | Hogan Lovells
The United States Food and Drug Administration (FDA) has finalized its tips “Electronic Submission Template for 510(k) Medical Device Submissions”, which will require 510(k) medical device submissions to use the FDA’s Electronic Submission Template and Resource (eSTAR) format, effective on October 1, 2023. Prior to this deadline, device manufacturers should prepare for this transition and prepare to submit 510(k) information electronically using eSTAR.
Continuation in September 2021 orientation project of the same name, the new FDA final direction “Electronic Submission Template for Medical Device 510(k) Submissions” will require all 510(k) submissions – including original submissions for traditional, special, and abbreviated 510(k), as well as subsequent supplements and amendments ( changes include records and appeals), and any subsequent submission to an original submission (unless specifically excepted) – to be submitted to the agency electronically using a pre-specified format.
The FDA electronic submission template and resource (eSTAR) is the only electronic submission template currently available to facilitate the preparation of 510(k) electronic submissions, specify the final guidelines. The FDA had announced the launch of the eSTAR pilot program in February 2020, as we summarized online here. Explaining the benefits of eSTAR, the final guidelines cite how “eSTAR is structured to collect and assemble 510(k) submission content as an electronic submission that closely follows the content of the ‘SMART’ 510 review memo template. (k) used by » FDA Center for Devices and Radiological Health (CDRH) reviewers.
Compared to the draft guidelines, this week’s final guidelines expand the scope of related submissions that will need to be submitted via the eSTAR format, specifically noting responses to requests for additional information. The final guidelines add a few limited exemptions to the 510(k) electronic submission requirements:
- Responses to interactive reviews;
- Some amendments:
- Supervisory control calls/requests;
- Background abstract requests;
- Modification of the corresponding modifications; and
- Changes after final decision (i.e. addition to files).
By comparison, the draft guidelines said the FDA had “identified no appropriate circumstances” for an exemption from the 510(k) electronic submission requirements. However, the final guidelines continue to clarify the draft guidelines that waivers will not be available for 510(k) electronic submission requirements. As a result, all 510(k) notices and nearly all related submissions will need to be filed using the eSTAR format and submitted to the FDA through its new Customer Collaboration Portal that went live earlier this year.
The FDA says it will only accept 510(k) submissions that are mailed or delivered to the agency if received by October 1, 2023. That date contemplates a one-year transition period for enable businesses to prepare for how to submit 510(k) information using eSTAR. Meanwhile, medical device companies need to plan for this transition, including arranging the logistics for using this format and for submitting through the portal.