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USQSR 21 CFR 820

# US Quality System Regulation

FDA's Quality System Regulation (21 CFR Part 820) establishes requirements for quality management systems in medical device manufacturing. Understanding QSR subsystems, documentation, and compliance is essential.

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At a glance

Key requirements

4

QSR subsystems

6

FAQs

5

## Key requirements

### Quality Management System

Establish and maintain a quality system appropriate for the specific medical device(s) manufactured.

**Applies to:** All medical device manufacturers

### Design Controls

Design and development procedures to ensure devices meet intended use and user needs.

**Applies to:** Class II and Class III devices, some Class I

### Document Control

Procedures for document approval, distribution, and change control to ensure consistency.

**Applies to:** All quality system documents

### Corrective and Preventive Action (CAPA)

Procedures to investigate and correct quality problems and prevent recurrence.

**Applies to:** All quality issues and nonconformities

## QSR subsystems

Management Controls

Quality policy, management responsibility, quality audit, and personnel requirements.

Design Controls

Design and development planning, input, output, review, verification, validation, and transfer.

Production and Process Controls

Production processes, validation, equipment, contamination control, and process changes.

Acceptance Activities

Acceptance procedures for incoming, in-process, and finished device testing.

Nonconforming Product

Control of nonconforming product including identification, evaluation, and disposition.

CAPA

Corrective and preventive action procedures for investigating and correcting quality problems.

## Documentation requirements

Quality Manual

Document describing the quality management system and how it meets QSR requirements.

SOPs

Standard Operating Procedures for each quality system activity.

Device Master Record (DMR)

Document containing specifications, procedures, and acceptance criteria for finished device.

Device History Record (DHR)

Record of production for each batch or unit showing compliance with DMR.

Design History File (DHF)

Compilation of records describing design of a device.

## Common compliance mistakes

Incomplete design controls - design controls are critical for Class II/III devices

Poor CAPA procedures - CAPA is a major FDA inspection focus

Inadequate document control - document control issues are common findings

Not validating processes - critical processes must be validated

Missing DHR documentation - DHR must be maintained for each production batch

Insufficient training - personnel must be trained on quality procedures

## Frequently asked questions

### What is Quality System Regulation (QSR)?

QSR (21 CFR Part 820) is FDA's quality system regulation for medical devices. It establishes requirements for quality management systems covering design, production, and distribution. QSR applies to all medical device manufacturers and is a key focus of FDA inspections.

### Do all devices require design controls?

Design controls are required for Class II and Class III devices. Some Class I devices may also require design controls if they have specific requirements. Check your device classification to determine if design controls apply.

### What is the difference between DMR and DHR?

DMR (Device Master Record) is the master document containing specifications and procedures for the device. DHR (Device History Record) is the production record for each batch or unit showing it was manufactured according to the DMR.

### What is CAPA and why is it important?

CAPA (Corrective and Preventive Action) is the process for investigating quality problems, correcting them, and preventing recurrence. CAPA is a major FDA inspection focus and demonstrates effective quality management.

### How do I prepare for a QSR inspection?

Prepare by ensuring your quality system is fully implemented and documented. Conduct internal audits, train personnel, ensure records are complete and accessible, and perform mock inspections. Review FDA inspection guides and common findings.

**Disclaimer:** This guide provides general information about QSR requirements. Facility-specific determinations require analysis of FDA regulations. Always verify current requirements with FDA resources or qualified compliance professionals.

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