Case for Quality – Overview

In 2011, the FDA introduced the Case for Quality program to support manufacturing practices that consistently meet high-quality standards while aligning with FDA laws and regulations. Since 2014, the FDA has collaborated with MDIC and other stakeholders to strengthen ties with the medical device industry, launching initiatives that encourage sustained, predictive practices. These efforts aim to enhance device quality and safety, ultimately improving patient outcomes.

Focusing on quality aims to provide benefits across the healthcare ecosystem, including potentially faster patient access to high-quality devices and greater confidence in their performance. Predicting and managing risks may help manufacturers reduce costs and improve profits, making quality a strategic, long-term investment for patient safety and organizational success.

The Case for Quality program stemmed from an in-depth FDA review of device quality data and feedback from industry stakeholders. This review identified common manufacturing risks that affect product quality and demonstrated how addressing these risks leads to improved outcomes including higher productivity, fewer complaints, and reduced quality-related costs. This transformative movement required active collaboration among regulators, industry, providers, payers, and patients to pave the way for a cultural shift toward prioritizing quality.