Actigraphy Enhanced Clinical Chronic Lower Back Pain Management: Sleep Algorithm Assessment

Project Summary The successful completion of our final Phase I SBIR milestone for our Fast-Track SBIR award requires us to obtain FDA 510(k) clearance for our VERABANDTM medical device. Our 510(k) application is currently about half-way though the FDA’s Substantive Review process. However, recently we received an unanticipated Additional Information request from the FDA that required us to increase the scope of the project beyond what was originally proposed by including a sleep-related assessment measure in the report we provide to physicians. Incorporating this measure while ensuring our quality system and Device History File remains compliant with the FDA’s Quality System Regulation, requires us to re-validate the software that generates the reports. The inability to complete these tasks in a timely manner may result in rejection from the FDA review process. This application requests additional support to complete the work required by the increased scope of the project so that we can successfully complete the FDA review and obtain 510(k) clearance for the VERABANDTM technology. This will allow us to advance to Phase II and onward toward commercialization.