21 CFR Part 820 - Quality System Regulation

This mandate outlines the essential quality management protocols that medical device developers must implement to guarantee product safety and efficacy. It governs the entire production lifecycle, ranging from initial design and manufacturing to final installation and servicing.

Overview

Background

Enforced by the U.S. Food and Drug Administration (FDA), this framework is codified under 21 CFR Part 820. While it has traditionally stood as the specific benchmark for the United States, the agency is actively transitioning towards harmonizing these rules with international standards such as ISO 13485.

Applicability

Compliance is mandatory for any organization intending to commercially distribute medical devices within the United States market. This includes a wide array of stakeholders, such as specification developers, contract manufacturers, repackagers, and those responsible for device installation or maintenance.

Core Principles

Systematic corrective and preventive action

Data-driven quality analysis and investigation

Comprehensive documentation and record controls

Rigorous design and development controls

Production and process quality assurance

Supplier evaluation and purchasing controls

Identification and control of nonconforming product