Case Study: US Food and Drug Administration (FDA) achieves faster, standardized 510(k) electronic reviews and improved data quality with Appian

How can we transform operations that were last modern 20 years ago to meet today’s expectations

The U.S. Food and Drug Administration (FDA) needed to modernize a 510(k) premarket review process that hadn’t been updated in decades. Reviews were localized and paper-based, with critical data stuck in text documents, document sharing handled by legacy tools and network drives, and inconsistent training—hindering speed, accountability, and timely decision-making.

Appian delivered an integrated electronic iReview workflow that unified legacy systems and supported 150+ users processing 3,500+ 510(k) reviews annually. The solution standardized and automated the review process, improved data quality, and enabled performance measurement—resulting in consistent, repeatable reviews, faster responses, and better-informed regulatory decisions.

US Food and Drug Administration (FDA)