In 2011, CDRH launched the Case for Quality initiative in an effort to shift the focus of industry and FDA from one of compliance and enforcement to one of quality ownership, based on the concept that a focus on quality ownership will improve product quality and patient safety, while naturally resulting in compliance. As the Case for Quality work has progressed, FDA has continually engaged industry members through the Medical Device Innovation Consortium (MDIC), which is a public/private partnership established by Dr. Jeff Shuren (CDRH Center Director). Dr. Shuren has indicated that reductions in certain regulatory oversight (pre-market and post-market) will be granted to those demonstrating mature quality ownership.
Through MDIC, CDRH launched a pilot study in 2017 designed to test the effectiveness of a maturity model established through an MDIC working team of FDA and industry members. As the pilot nears the halfway point, CDRH would like to engage industry members in a workshop to discuss the Case for Quality:
As a primer to the Case for Quality Workshop at Xavier, it would be beneficial for attendees to listen to the February 27th MDIC Quarterly update webinar on the “CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program.” Attendees will be in a better position to provide meaningful input to the FDA if the background is understood prior to joining us at Xavier.