About
MDIC, in collaboration with industry and FDA, has launched the Accelerate Sustainable Capability (ASC) pilot, which leverages lessons learned from the existing Case for Quality Voluntary Improvement Program (CfQ VIP) and modifies its use for 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 improvements 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 safety throughout the process.
Note: Firms that have shown cooperation with the Agency will be prioritized for the purpose of this pilot.
Directions
The Medical Device Innovation Consortium (MDIC) would like to thank you for your interest in the Accelerate Sustainable Capability (ASC) Pilot. Please complete the following application to the best of your ability. The form will be reviewed by MDIC and then sent to FDA for their recommendation. MDIC will notify your site of its application status within 1-2 weeks of receipt.