FDA Announces Pilot for PDF-Based 510(k) Template

The FDA has launched a voluntary pilot program for testing out its new interactive, PDF-based 510(k) submission template.

The template, called the electronic Submission Template and Resource (eSTAR), is “a more dynamic electronic format capable of organizing the complex information” required in 510(k) applications for agency review, according to CDER Director Jeff Shuren.

“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,” he said.

The agency will select up to nine participants for the pilot program.