The Accelerate Sustainable Capability (ASC) Pilot Study 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 FDA 483 and/or advisory 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.
The pilot study is now open for applicants. The application period will remain open until nine sites have been approved for participation. Your site will be notified by MDIC of its pilot application status within two weeks.
The ASC Pilot Study is an MDIC study defined in collaboration with medical device industry, ISACA and FDA. Read the FDA’s announcement of the MDIC ASC Pilot Study here.
Contact MDIC CfQ Program Director Alan Baumel if you have questions.