Through the Case for Quality, the FDA is working with stakeholders—industry, healthcare providers, patients, payers, and investors—to foster medical device quality. FDA's Case for Quality is intended to openly engage all members of the device ecosystem. Enhancing the quality of medical devices is in the best interests of all, especially industry and patients. This is achieved by identifying and promoting practices that result in high-quality devices and adapting FDA regulatory approaches to align with those practices. Ultimately, this provides stakeholders with understandable and objective information about medical device quality; facilitates medical device innovation and quality through data and analysis on device performance; and fosters strategies that focus stakeholder interactions on device quality.
The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. The FDA's analysis flagged manufacturing quality risks and showed that firms that manage those risks by driving quality organization-wide are more productive, with fewer complaints and investigations per batch, and often with smaller quality units with lower quality-related costs than their competitors. In other words, investing in quality pays.
The Case for Quality is part of CDRH's 2016-2017 strategic priority to promote a culture of quality and organizational excellence.
The Case for Quality consists of three core components:
Historically, the FDA has evaluated manufacturers' compliance with regulations governing the design and production of devices. The Focus on Quality initiative teats compliance as a baseline, giving greater emphasis to the FDA and stakeholders focusing on critical-to-quality practices that correlate to higher quality outcomes. The FDA is working with stakeholders to promote manufacturers' implementation of critical-to-quality practices in day-to-day device design and production. The FDA is also looking for ways to recognize these practices in its own operations.
As part of the Focus on Quality, the FDA launched a pilot that established a collaborative framework for determining specific operations, design considerations, and controls that impact the quality and safety of implantable devices that use batteries. The FDA is developing an inspectional approach that focuses on those specific operations, design considerations, and controls. Pilot participants will collaborate with the FDA on outcome measures to evaluate the effectiveness of this approach. More information about the pilot can be found in the Battery Critical to Quality(CtQ) Pilot report.
The FDA Library of Quality Practices helps medical device professionals seeking to identify tools for developing and updating their approach to quality in the design and manufacturing of medical devices. The development of the FDA Library of Quality Practices 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 resources to the library.
The FDA receives a broad array of quality-related data, including information from recall and adverse event reports and inspection results. The FDA proposes to leverage this data through multiple strategies that support device quality. For example, to enhance independent analyses by stakeholders, the FDA is exploring publishing our data so that it can be automatically accessed and searched by external analytical tools. We're also conducting analyses of our data and publishing these analyses. These reports will draw from our recall data as well as inspectional observations and warning letters.
Since this effort launched, FDA staff has met with stakeholders regularly to present the Case for Quality and solicit feedback. The feedback has allowed us to approach medical device compliance and quality more collaboratively, and to launch initiatives that vary from our traditional oversight models. As we move forward, we continue discussions with stakeholders about specifically-selected topics.
Benefit of the Case for Quality
The Case for Quality allows the FDA to collaborate with stakeholders to identify and share important quality practices.
The Case for Quality also allows the FDA to use quality practices to guide its oversight of manufacturers. This results in greater transparency and predictability when the agency inspects device makers. Companies will better understand what to expect during an FDA inspection and will be better informed about how to meet quality elements for their devices.
Beyond greater transparency and predictability, quality-linked device design and production enhances manufacturers' bottom-line. One study found that adopting quality practices, like ones currently in place by top quality performers, could reduce quality-related costs to manufacturers by 20-30%, increasing profits by three to four percent. This quality improvement pays dividends in customer satisfaction and provides significant competitive advantages.
Better-quality devices help the FDA to meet its mission of protecting and promoting the public health. In addition, the Case for Quality allows the FDA to identify quality-capable firms so that we can better utilize our limited compliance resources.
As important, stakeholders such as hospitals, payers, health care provides, and patients benefit from increased product quality and the increased confidence that the devices they rely on will perform as intended.
CDRH 2016-2017 Strategic Priorities(PDF - 249KB)
- AdvaMed Library of Quality Practices
- ASQ Library of Quality Practices
- Medical Device Innovation Consortium (MDIC) Case for Quality
Medical Device Recall Report, FY2003 to FY2012(PDF - 818KB) Understanding Barriers to Medical Device Quality openFDA: Devices - Recall Enforcement Reports CDRH Transparency: Compliance & Enforcement