December 3, 2019

This whitepaper is the result of a collaborative effort of the Medical Device Innovation Consortium (MDIC), the medical device industry, strategy consultants, and the Food and Drug Administration (FDA). It brings together their perspectives and cultural and procedural best practices across various industries to recast the Corrective and Preventive Action (CAPA) process as a continuous improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The paper summarizes the initial findings and recommendations developed by the joint team, including a proposed framework for risk-based improvement. We recommend that industry participants test the framework in a live pilot. This paper does not constitute advocacy or lobbying or present recommendations on policy or political matters. Moreover, although FDA representatives on the program team are supportive of the framework, this paper does not represent conclusions or policy changes by the agency.