Quality Systems in Medical Technology Manufacturing

FDA regulations ensure that medical technologies are manufactured to the strictest possible standard so that companies consistently produce high-quality medical devices.

FDA's “quality system” regulations go beyond making sure that basic manufacturing operations are controlled, however. Medical technology companies are required to establish detailed procedures to control every aspect of a device's lifecycle, from early in the design phase to commercial distribution. Manufacturers collect and analyze information at each of these steps and use that data to continually improve their operations and create the next generation of innovative products.

Manufacturers also must ensure that any supplier or contractor that provides a component, raw material or service that could affect the final medical device adheres to strict quality standards as well. Finally, FDA regulations place the ultimate responsibility for the quality of a medical technology with top company executives.

FDA conducts periodic inspections of medical technology companies to ensure that their manufacturing operations comply with the high-quality standards called for in medical device regulation.

FDA manufacturing requirements stress quality throughout the life of a medical technology.

FDA manufacturing regulations are structured so that quality is built into a medical technology at every phase of a device's life – from design to pre-production to full-scale production to market commercialization. Medical technology companies must tightly control each of these steps and continually gather information to improve their processes and their products.

• Design controls cover every aspect of a medical technology's early development, from working concept to final prototype.

• Production and process controls ensure manufacturing operations and equipment will consistently meet predetermined specifications.

• Acceptance activities require periodic assessment of production items and components at the beginning, middle and end of a manufacturing operation.

• Customer input, service reports other after-market data must be collected and analyzed for potential areas of improvement.

FDA regulations also require top executives at medical technology companies to take full responsibility for the quality of their products and processes by being actively involved in key decisions that can affect quality. Furthermore, top executives must ensure that a company's commitment to quality is communicated and understood by all levels of employees.

A crucial component of FDA's manufacturing regulations is the requirement that medical technology companies establish procedures to quickly correct any problems that develop with a product or a process and to work proactively to ensure that such problems do not occur again. This requirement safeguards U.S. consumers by catching medical device problems before they leave the factory floor.

Medical technology manufacturers have high compliance rates with FDA requirements.

FDA conducts comprehensive inspections of medical technology manufacturers to ensure that their operations are in compliance with quality system requirements. These inspections can occur at any time, with little or no warning; often involve teams of trained auditors; and last from several days to several weeks.

Compliance rates of medical technology companies with FDA manufacturing regulations have remained consistent over the last several years. Approximately 85 percent of the medical technology companies inspected by FDA have no compliance problems or minor deficiencies that are easily corrected. The remaining companies that do receive an FDA censure typically have excessive paperwork or record-keeping discrepancies, problems that usually do not affect the safety or effectiveness of a medical technology.

If FDA were to discover a situation where a manufacturer was producing a medical technology that could pose a risk to patients, the agency has the authority to immediately halt production at that facility. However, such circumstances are rare.

Medical technology manufacturers strive to deliver high quality medical technologies and comply with FDA's manufacturing requirements because it furthers their mission of providing innovative products that save and improve peoples' lives

Manufacturers that fail to provide safe and effective medical technologies or to adhere to FDA manufacturing requirements could be subject to FDA citations, detention or seizure of their products, heavy civil monetary penalties and criminal prosecution, loss of sales to competitors, and major product liability lawsuits.

-April 2004