The FDA has begun a pilot program to make its medical device clearance process less cumbersome for applicants.
With the electronic Submission Template And Resource (eSTAR) program, the application’s content is embedded within a PDF document so applicants can more easily develop, view and edit a 510(k). The agency said it will select up to nine applicants who represent the breadth of the medtech industry to participate in the pilot.
Applicants’ statutory and data requirements will remain the same, and the eSTAR templates resemble the FDA reviewers’ template. The applicants’ pilot templates represent “a more dynamic electronic format capable of organizing the complex information necessary for a robust scientific review,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release.
“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,” Shuren added. “eSTAR is intended to improve our overall productivity, enabling the agency’s review staff to put more of our time and resources into evaluating applications for devices that pose the highest potential risks to patients. Additionally, eSTAR is a step toward fulfilling our Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment to streamline the premarket notification review submission process, which is also part of the FDA’s ongoing effort to ensure that we’re giving patients more timely access to safe, effective and high-quality medical devices.”
More information is available here.