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FDA Compliance

When Inspections and Regulations Leave Quality Lacking, Try This

A Case for Quality is changing medical device manufacturers focus and FDA’s approach

Published: Wednesday, December 2, 2015 - 17:33

Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms.

The metrics and assessment tools being developed are key parts of the Case for Quality (CfQ). We are working with a wide variety of stakeholders—including the medical device industry, patients, other governmental and academic colleagues, and payer/provider counterparts—to identify and promote practices that will result in higher quality devices.

The CfQ was launched in October 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. FDA’s analysis flagged manufacturing quality risks and showed tremendous benefits for firms that drive quality organizationwide. They receive fewer complaints and internal investigations per batch of devices manufactured, often house smaller quality staffs, and have lower quality-related costs, compared with competitors.

In the four years since the conclusion of the analysis, FDA has continued to observe that the percentage of inspections calling for official action by FDA has remained static, with the same issues recurring frequently year after year. Given this observation, in addition to FDA inspecting device firms on a regular basis, we are thinking about other ways to support quality beyond inspections and traditional regulatory approaches.

FDA introduced the CfQ in an effort to help device manufacturers elevate their focus from the baseline requirements of compliance with regulations alone, and instead focus on predictive and proactive measures they can take independently to improve quality. CfQ also provides FDA the opportunity to change our approach to focus more on what matters most in assuring product and manufacturing quality and safety for patients.

The CfQ has three priorities for addressing the barriers that were identified:

1. Focus on quality. FDA and CfQ stakeholders consider compliance to be a baseline, and have shifted our focus increasingly to characteristics and practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes. Through the CfQ, we are collaborating with internal and external customers to identify characteristics that are critical to the quality of a particular device. This will result in a shared understanding of product features and manufacturing processes most important to patient safety.

2. Stakeholder engagement. FDA works closely with the device industry and a broad group of customers to collaborate on CfQ and solicit feedback. This effort recognizes the extraordinary impact that engagement and agreement among regulators, industry, patients, providers, and payers can have on device quality.

3. Data transparency. FDA receives a broad array of quality-related data, including information from recalls and adverse event reports. To support device quality, FDA has made device data (except certain information that we are prevented by federal law and regulations from disclosing) available on open.fda.gov.

The outcomes of the CfQ will allow stakeholders to focus resources on activities with the greatest impact on assuring that patients and users receive high-quality devices. This effort brings together metrics, successful quality practices, and our partnerships with stakeholders to promote quality and excellence in the medical device industry. It reflects our commitment to ensuring that devices perform as intended, meeting FDA’s mission of protecting and promoting public health.

This article first appeared Nov. 12, 2015, in FDAVoice.


About The Authors

Howard Sklamberg’s picture

Howard Sklamberg

Howard Sklamberg is FDA’s deputy commissioner for global regulatory operations and policy, and he is the directorate comprising the Office of Regulatory Affairs and the Office of International Programs. Sklamberg provides executive oversight, strategic leadership, and policy direction to FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. Sklamberg played leadership roles in global drug supply chain security, pharmacy compounding oversight, pharmaceutical quality, and expanded cooperation with international regulatory partners. Sklamberg has degrees from Harvard Law School, Yale University, and Fletcher School of Law and Diplomacy.

Jeffrey Shuren’s picture

Jeffrey Shuren

Jeffrey Shuren is the director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy. Shuren received his bachelor’s and doctor of medicine degrees in medical education from Northwestern University under its Honors Program.

Melinda Plaisier’s picture

Melinda Plaisier

Melinda Plaisier is the associate commissioner for regulatory affairs at the Food and Drug Administration. She leads more than 4,300 employees and operations in the Office of Regulatory Affairs (ORA). Plaisier helps the FDA adapt to the continuing program-based and in implementing FDA’s expanded authority. Prior to FDA Plaisier worked for 13 years in the U.S. Congress for the Office of the Commissioner directing and managing the agency’s congressional relations and legislative activities. She also served as the associate commissioner for international programs where she focused on negotiating international agreements and working with developing nations.