The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic submissions for 510(k) premarket notifications for medical devices other than in vitro diagnostic tests. Participation in the program is limited, among other criteria, to companies that plan to submit at least one 510(k) for a device that contacts body tissue and includes software.

On February 26, 2020, FDA announced the launch of the electronic Submission Template And Resource (eSTAR) pilot program for 510(k) submission as part of the ongoing transition to electronic-only submissions. The eSTAR program is intended to improve consistency and efficiency in industry preparation and agency review of premarket notifications (510(k) Notices).

The eSTAR pilot features an automated PDF electronic submission template that complements the CDRH internal review templates and provides automatic verification that will not require Refuse to Accept review.

The eSTAR program differs from the eSubmitter software (Quality in 510(k) Review Program Pilot) created in October 2018 in that it uses a PDF form rather than requiring downloading of software; it allows for the addition of comments, pictures, and dynamic pop-up text; it supports supplements and amendments; and it provides user interface with mobile devices.

FDA is seeking statements of interest for participation and plans to accept up to nine participants. Eligible companies must

  • intend to submit a 510(k) for a medical device (not a combination product) within three months of acceptance into the program;
  • provide feedback on the eSTAR based on a series of targeted questions; and
  • intend to submit at least one 510(k) for a device that contacts the body tissue and includes software.

Next steps

To request participation in the pilot, send an email to eSubPilot@fda.hhs.gov that includes the following information:

  • A statement requesting participation in the pilot
  • Applicant Name
  • Device Trade Name(s)
  • Contact Name
  • The size of the company by specifying the number of personnel and the amount of revenue per year
  • Agreement to the selection qualities identified in section I.A of the Federal Register Notice
  • The devices that are likely to be submitted during the pilot program using eSTAR
  • A statement that a Traditional, Abbreviated, or Special 510(k) will be sent to FDA within 3 months of the emailed acceptance date
  • A statement that at least one 510(k) will be for a device that is a software enabled tissue contacting device (i.e., eSTAR will contain biocompatibility and software documentation)

FDA is also requesting responses from stakeholders outside the pilot who want to submit comments to the docket.