MDICx: Overview of the CDRH 510(k) Improvement Project

April 4, 2019, 1 p.m. ET/12 p.m. CT/ 10 a.m. PT

In 2017, MDUFA IV set new goals for average time to decision (TTD) for 510(k) submissions. Several initiatives were launched at CDRH to help achieve these goals, including the 510(k) Improvement project in the CDRH Office of Device Evaluation (ODE) and Lean Six Sigma in the CDRH Office of Quality Management and Organizational Excellence (QM/OE). This MDICx webinar will describe the 510(k) Improvement project, its current state, and ties to Case for Quality (CfQ).


  • Jeff Slutsky, NSigma Solutions Inc.
  • Francisco Vicenty, US FDA Center for Devices and Radiological Health

Download Slides

View the Webinar: