All terms
Quality System Regulation
FDA's current good manufacturing practice (cGMP) requirements for medical devices.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
The Quality System Regulation (21 CFR Part 820) sets out the cGMP requirements that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for human use. What the regulation says
The FDA's Quality System Regulation (21 CFR Part 820) establishes current good manufacturing practice (cGMP) requirements for medical devices, ensuring devices are safe and effective. It details requirements for quality system elements such as management responsibility, design control, purchasing, production and process controls, and corrective and preventive actions. Although the QSR is being replaced by the Quality Management System Regulation (QMSR) which harmonizes with ISO 13485:2016, its principles remain foundational for device quality.What this means in practice
FDA has harmonized the QSR with ISO 13485:2016 in the Quality Management System Regulation (QMSR), which becomes effective in 2026. Manufacturers must align procedures with the new framework.Examples
- A medical device manufacturer implements a robust design control process, as required by 21 CFR 820.30, ensuring that device requirements are defined, reviewed, and validated before production.
- During an FDA inspection, a company demonstrates its adherence to 21 CFR 820.70 by providing records of equipment calibration and maintenance for manufacturing machinery.
- A MedTech company establishes a corrective and preventive action (CAPA) system, in line with 21 CFR 820.100, to address nonconformities and prevent their recurrence.
Common pitfalls
- •Misinterpreting "harmonization" to mean identical, as there will still be FDA-specific requirements in the QMSR beyond ISO 13485:2016.
- •Failing to adequately document design control activities, leading to challenges during FDA inspections.
- •Assuming that compliance with ISO 13485:2016 automatically means full compliance with 21 CFR Part 820 without addressing FDA-specific nuances. Quality System Regulation (21 CFR Part 820) compliance is mandatory for medical devices marketed in the United States, while ISO 13485:2016 is a globally recognized voluntary standard that often satisfies QSR requirements.
- •Neglecting to update quality system procedures and training to reflect the specific requirements of the Quality System Regulation (21 CFR Part 820) when operating in the US market, even if compliant with other international standards.
- •Underestimating the importance of robust complaint handling and medical device reporting (MDR) as outlined in 21 CFR Part 820 Subpart M, which are critical for post-market surveillance.
Frequently asked questions
The primary purpose is to ensure that medical devices are safe and effective for human use by requiring manufacturers to follow current good manufacturing practices.
Cross-references
Contains
Replaced by
Overlaps with
Related terms
Shared paths + categoryQuality & Risk
Quality Management System Regulation(QMSR)
FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
QMS Foundations · adjacent
Quality & Risk
Corrective and Preventive Action(CAPA)
Systematic process to investigate and resolve quality issues and prevent recurrence.
QMS Foundations
Quality & Risk
Design Controls
Structured process governing the design of medical devices.
QMS Foundations
Standards
ISO 13485
International standard for medical device quality management systems.
QMS Foundations
Quality & Risk
Complaint Handling
Process for receiving, evaluating, and responding to device complaints.
QMS Foundations
Quality & Risk
Design History File(DHF)
Compilation of records describing the design history of a finished device.
QMS Foundations
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
eCFR·1FDA·1ISO·1
- 1Quality System Regulation (21 CFR 820)VerifiedeCFRecfr.gov
- 2FDA - Quality SystemsVerifiedFDAfda.gov
- 3ISO 13485 Standard PageVerifiedISOiso.org
Inline markers like [1] jump to the matching reference above.