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  1. Quality and Compliance (Medical Devices)

Case for Quality

One of the top priorities for FDA's Center for Devices and Radiological Health is a focus on high quality products which will better protect and promote public health.

As part of this effort, the FDA is working with stakeholders—industry, health care providers, patients, payers, and investors—to build a strong Case for Quality program.

The Case for Quality program is intended to help the FDA identify device manufacturers that consistently produce high-quality devices. It will allow the FDA to identify participants with manufacturing practices that are of consistently high quality that also align with the laws and regulations implemented by FDA. Finally, the program is designed to identify successful manufacturing practices to help other device manufacturers raise their manufacturing quality level.

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 certain widespread or common manufacturing risks that impact product quality. The review also showed manufacturers that focus on and manage those risks often become more productive, receiving fewer complaints, needing to open fewer Corrective and Preventive Actions and investigations, and having lower quality-related product costs than their competitors.

In simple terms, the review identified that an investment in quality has long-term payoffs.

Benefits for Industry, Health Care Providers, and Patients

Focusing on the quality of medical devices is in everyone's best interest.

Medical device manufacturers can reduce costs and increase their profits by focusing on quality measures during medical device design and production. This quality improvement approach pays dividends in customer satisfaction and provides significant competitive advantages. The Case for Quality program helps the FDA and manufacturers understand and sustain the link between a quality improvement approach and the benefits such approach provides.

Increased product quality also benefits hospitals, payers, health care providers, and patients by generating confidence among them that the devices they rely on will perform as intended. Additionally, focusing on quality measures can allow for a smoother submission review process and therefore a faster access to high-quality devices for consumers.

Ultimately, the Case for Quality focuses on objective information about medical device quality; facilitates medical device innovation through data, processes, and analysis of device performance; and fosters strategies that focus stakeholder interactions on device quality.

Core Components

The Case for Quality consists of two core components:

Focus on Quality

While the FDA usually evaluates a manufacturer's compliance based on the regulations governing the methods used in, and the facilities and controls used for, the design and production of devices, the Focus on Quality initiative goes above and beyond by treating compliance attainment as the baseline and by looking for the inclusion of critical-to-quality practices that result in improved quality outcomes. The FDA is working with stakeholders to promote manufacturers' implementation of critical-to-quality practices during device design and production. These practices range from design improvements to meet customer needs to controlling production errors and increasing speed of detection for quality issues. The FDA is also looking for ways to recognize these practices in its own operations.

The FDA Library of Quality Practices helps medical device professionals identify tools for developing and updating their quality approach to 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 and maintaining device quality. The American Society for Quality (ASQ) and AdvaMed have contributed resources to the library.

Stakeholder Engagement

The FDA works with the Medical Device Innovation Consortium (MDIC) and other stakeholders on Case for Quality to approach medical device compliance and quality more collaboratively, and to launch initiatives that vary from our traditional oversight models. As part of this commitment, we continue discussions with stakeholders at Case for Quality public meetings and forums.

Learn about how to participate in Case for Quality pilot programs

Related Links


Contact FDA

1 (800) 638-2041
(301) 796-7100

Information-Medical Devices / Radiation Products
Division of Industry and Consumer Education

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