Announcing the FDA Library of Medical Device Quality Practices

The FDA’s Library of Quality Practices is a resource for medical device professionals seeking to identify tools that can help them develop and update their approach to quality in the design and manufacturing of medical devices.

These resources were developed as part of FDA’s Case for Quality initiative, and are intended to promote a culture of quality and organizational excellence through CDRH's 2016-2017 Strategic Priorities. Historically, the FDA and industry has focused on manufacturers’ compliance with regulations governing the design and production of devices. The Focus on Quality initiative considers compliance as a baseline expectation, emphasizing the need for FDA and its stakeholders to focus on critical-to-quality practices that correlate to higher quality outcomes. The development of the FDA Library of Quality practices project enables the FDA and industry partners to leverage existing knowledge and engage collaboratively with the goal of improving device quality. The American Society for Quality (ASQ)and AdvaMed have contributed to the library.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health