Medical Devices

Quality System Regulation(QSR)

FDA regulations governing the methods and facilities used in the manufacture of medical devices.

Usage Examples

The facility was inspected for QSR compliance.
QSR design controls apply to Class II and III devices.
The FDA 483 cited QSR CAPA deficiencies.

What is QSR?

The Quality System Regulation (QSR, 21 CFR Part 820) establishes quality system requirements for medical device manufacturers. It's based on international standards and is being updated to align more closely with ISO 13485.

QSR covers management responsibility, design controls, document controls, purchasing controls, production and process controls, corrective and preventive action, labeling, handling/storage/distribution, and servicing.

The 2024 FDA update (QMSR - Quality Management System Regulation) incorporates ISO 13485 by reference, reducing redundancy for manufacturers seeking global compliance.

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 820, ISO 13485.

FDA CDRHEMAHealth Canada

When This Matters

The facility was inspected for QSR compliance.
QSR design controls apply to Class II and III devices.
The FDA 483 cited QSR CAPA deficiencies.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 820ISO 13485

Frequently Asked Questions

QSR applies to manufacturers of finished medical devices. Some provisions don't apply to Class I devices exempt from design controls, component manufacturers, or certain reprocessors.

Both establish quality management requirements for medical devices. The QMSR update incorporates ISO 13485 by reference, meaning compliance with ISO 13485 will largely satisfy FDA QSR requirements.