FDA’s eSTAR Pilot Seeks to Improve Efficiency, Consistency of 510(k) Submission Process


Posted March 3, 2020

The Food and Drug Administration (FDA)’s newly launched electronic Submission Template And Resource (eSTAR) pilot program aims to improve the efficiency and consistency of premarket 510(k) submissions.

The agency will be selecting up to nine medical device manufacturers to participate in the voluntary eSTAR program, the intention of which is to “aid both industry and FDA staff in using resources effectively.” The design and structure of eSTAR templates, which include features such as automation (e.g., form construction, autofilling), integration of multiple resources (e.g., guidance documents, databases), and guided construction for various submission sections, are similar to templates used by FDA reviewers.

“As technology advances, the FDA must keep pace with the increasing complexity of rapidly developing technology and continue to modernize and evaluate our programs and processes, ensuring they continue to be efficient, consistent and scientifically rigorous,” said Jeffrey Shuren, director of the FDA CDRH, in a statement. “Without changing our statutory or data requirements, this highly interactive submission template is intended to allow manufacturers to provide information to the FDA that’s complementary to CDRH [Center for Devices and Radiological Health] internal review templates currently used to review 510(k)s, allowing us to receive information and evaluate the submission more efficiently and consistently.”

Although using eSTAR submissions will not change the requirements that manufacturers need to fulfill in order to demonstrate substantial equivalence to a predicate device, Refuse to Accept reviews (i.e., preliminary reviews for ensuring that a submission is complete) will not be performed for eSTAR templates submitted for the pilot. Statements of interest for participating in the program are now being accepted. To participate in the eSTAR pilot program, manufacturers must meet a variety of eligibility criteria, as well as provide several items of information.

As described in the Federal Register notice, “To be considered for the voluntary eSTAR Pilot Program, a company should submit a statement of interest for participation to esubpilot@fda.hhs.gov. The statement of interest should include agreement to the selection qualities listed in section I.A. of this document, as well as a description of the device in enough detail to allow verification that it is not a combination product, and that it is a software enabled tissue contacting device.”

The Federal Register notice also includes a number of targeted questions for which the FDA is seeking input “from pilot program participants and stakeholders outside the pilot.” Among others, these questions include “Is eSTAR able to integrate into your organization's business process?,” “If you use Assistive Technology, are you able to navigate through and complete eSTAR?,” “If eSTAR is not intuitive to use, why?,” and “Is the organization and content in eSTAR as expected, or do you have suggestions for improvement?”