FDA Launches New Interactive 510(k) Template Program

US FDA announced the voluntary electronic Submission Template and Resource (eSTAR) Pilot Program as an alternate method available for selected industry participants in the pilot to prepare a 510(k) submission. With an eSTAR, the content of the premarket submission is embedded within a PDF document, which permits applicants more dynamic functionality when creating, review and editing a 510(k).

eSTAR is designed and structured in a similar format as FDA’s 510(k) reviewers’ Smart template, and consists of a series of questions, text, logic, and prompts that guides a user through guidance of a 510(k) submission. This template contains:

• Automation (e.g., form construction, auto filling);
• Content and structure that is complementary to CDRH internal review templates;
• Integration of multiple resources (e.g., guidance, databases);
• Guided construction for each submission section; and
• Automatic verification (i.e., FDA does not intend to conduct a Refuse to Accept review), and it is free to use.

eSTAR is planned to improve our overall efficiency, 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. Submissions utilizing an eSTAR do not change any statutory or information requirements for device sponsors to demonstrate their devices are considerably equivalent to a predicate device.

The FDA plans to evaluate whether the use of eSTAR produces well-organized submissions that can be reviewed more efficiently, in comparison to submissions prepared as eCopies or with the eSubmitter application, to assist promote timely access to safe, effective, and high-quality medical devices.