FDA Workflow Improvement Toolkit

Executive Summary

The 510K submission is a complex regulatory pathway that allows companies to obtain statutory clearance to distribute medical devices in interstate commerce. However, the majority of small start-up companies or device inventors cannot afford legal advisers or simply are too busy to read numerous complex guidances and standards. When inventors/start-ups move to the translational/pre-clinical stage they are not aware of regulatory requirements and often fail to commercialize the innovation. We want to improve sponsor and FDA reviewer communication to accelerate commercialization of safe and effective treatments to needed patients. Our product is a mobile platform addressing the HHS priority of applying Least Burdensome approach to accelerate innovation and development of new safe and effective treatments, through simplifying 510K pathway education, regulation, and communication between sponsors and FDA reviewers.

Team Members

Xavier-Lewis Palmer (Lead), FDA
Wojtek Tutak, FDA
Lucas Potter, FDA
Wilson Rodden, FDA
Akwasi Akwaboah, FDA

Milestones

October 2018: Project selected into the HHS Ignite Accelerator
June 2019: Time in Accelerator Began
September 2019: Time in Accelerator Ended