April 23, 2020

The CDRH Accelerate Sustainable Capability (ASC) pilot leverages lessons learned from the existing Case for Quality Voluntary Improvement Program (CfQ VIP) and modifies its use with sites that are experiencing issues and/or are under a compliance action.  The goal of this pilot is to test a methodology for providing systemic improvement to enable compliance actions to be closed faster and more sustainably while, at the same time, ensuring objective metrics and residual risk assessments are in place to provide the agency with oversight of product quality throughout the process.

Contact Program Chair, Kathryn Merrill and/or MDIC CfQ Program Director, Alan Baumel, if you have questions.