Medical Devices

Case for Quality

Through the Case for Quality, the FDA is working with stakeholders—industry, healthcare providers, patients, payers, and investors – to foster medical device quality. 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.

Core Components

The Case for Quality consists of three core components:

Focus on Quality

Historically, the FDA has evaluated manufacturers’ compliance with regulations governing the design and production of devices. The Focus on Quality goes beyond this model by treating compliance only as a baseline. The FDA and stakeholders focus instead on critical-to-quality practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes. The FDA is working with stakeholders to promote manufacturers’ implementation of critical-to-quality practices. The FDA is also looking for ways to account for these practices in its own actions, including possibly streamlining inspections when quality practices are present.

As part of the Focus on Quality, the FDA is launching a pilot that establishes a collaborative framework for determining specific operations, design considerations, and controls that impact the quality and safety of implantable devices that use batteries. FDA will develop an inspectional approach that focuses on those specific operations, design considerations, and controls and the participants will collaborate on outcome measures to evaluate the effectiveness of this revised approach.

Enhance Data Transparency

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.

Stakeholder Engagement

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, focusing limited compliance resources instead on companies that are less able to produce quality devices.

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.

Contact FDA

1-800-638-2041
301-796-7100
Fax:301-847-8149
CDRH-Division of Industry and Consumer Education (DICE)(formerly DSMICA)

Office of Communication and Education

Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

WO66-4621

Silver Spring, MD 20993

Page Last Updated: 07/28/2014
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