Following up on September 2021 draft guidance of the same name, FDA’s new final guidance “Electronic Submission Template for Medical Device 510(k) Submissions” will require all 510(k) submissions –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)s, and subsequent Supplements and Amendments (amendments include add-to-files and appeals), and any other subsequent submissions to an original submission (unless specifically exempted) – to be submitted to the agency electronically using a pre-specified format.

FDA’s electronic Submission Template And Resource (eSTAR) is the only currently available electronic submission template to facilitate the preparation of 510(k) electronic submissions, the final guidance specifies. 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 guidance cites how “eSTAR is structured to collect and assemble content in the 510(k) submission as an electronic submission that closely follows the content of the ‘SMART’ 510(k) review memo template used by” reviewers in FDA’s Center for Devices and Radiological Health (CDRH).

Compared to the draft guidance, this week’s final guidance expands the scope of associated submissions that will need to be submitted through the eSTAR format, specifically noting responses to Additional Information requests. The final guidance does add some limited exemptions to 510(k) electronic submission requirements:

• Interactive review responses;
• Certain amendments:
  • Appeals/requests for supervisory review;
  • Substantive summary requests;
  • Change in correspondent amendments; and
  • Amendments after final decision (i.e., add-to-files).

Comparatively, the draft guidance had said that FDA had “not identified any circumstances appropriate” for an exemption from the 510(k) electronic submission requirements. However, the final guidance continues the draft guidance’s clarification that waivers will not be available for the 510(k) electronic submission requirements. Accordingly, all 510(k) notices and nearly all associated submissions will be required to be filed using the eSTAR format and submitted to FDA through its new customer collaboration portal which went live earlier this year.

FDA says it will only accept 510(k) submissions that are mailed or delivered to the agency if they are received prior to October 1, 2023. This date contemplates a transition period of one year to allow companies to prepare for how to submit 510(k) information using eSTAR. During this time, medical device firms should plan for this transition, including sorting out logistics for using this format and for submission through the portal.

If you have any questions on using the eSTAR template, or on 510(k) submissions more generally, feel free to contact the Hogan Lovells attorney with whom you regularly work, or either of the authors of this alert. We will continue to track FDA’s advances with electronic submissions.

Authored by Lina Kontos and Randy Prebula