Achieving A Successful 510(k) to the FDA

The challenge:
An insulin pump manufacturer sought pre-market approval from FDA for two years. Each submission failed to satisfy the FDA’s concerns about deficiencies of the pump design. Our goal was to help the manufacturer achieve clearance by applying our expertise in human factors, user interface testing and risk mitigation in preparation for a 510(k) submission to FDA.

How we did it:
Leveraging our expertise in FDA requirements and regulations, we helped the manufacturer design a comprehensive human factors plan that satisfied the FDA. We shepherded the manufacturer through the human factors protocol, standing by every step of the way to help redesign when it was necessary to mitigate concerns exposed during user interface testing. At the conclusion of the process we assisted in conducting a summative study and generating a human factors report for inclusion in the 510(k) submission.

The result:
Success! The FDA awarded pre-market approval to the pump manufacturer, and the device was cleared in 5 months.