--- title: "QSR / 21 CFR 820, Quality System Regulation | MedTech Terms" description: "FDA's current good manufacturing practice (cGMP) requirements for medical devices. 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Quality System Regulation [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system)[Global Markets](/ecosystems/global-markets)QSR / 21 CFR 820 # Quality System Regulation FDA's current good manufacturing practice (cGMP) requirements for medical devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/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](/terms/safe-note) and effective. It details requirements for quality system elements such as management responsibility, design control, purchasing, [production and process controls](/terms/production-process-controls), and corrective and preventive actions. Although the QSR is being replaced by the [Quality Management System Regulation](/terms/qmsr) (QMSR) which harmonizes with [ISO 13485](/terms/iso-13485):2016, its principles remain foundational for device quality. ## What this means in practice FDA has harmonized the QSR with [ISO 13485](/terms/iso-13485):2016 in the [Quality Management System Regulation](/terms/qmsr) (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 What is the primary purpose of the Quality System Regulation? The primary purpose is to ensure that medical devices are [safe](/terms/safe-note) and effective for human use by requiring manufacturers to follow current good manufacturing practices. How does the Quality System Regulation relate to ISO 13485? Who must comply with the Quality System Regulation? Which areas does the Quality System Regulation cover? ## Cross-references ### Governs Things this term applies rules or requirements to. - [ 510(k) Premarket Notification(510(k)) ](/terms/510k) - [ Premarket Approval(PMA) ](/terms/pma) ### Contains Sub-elements or required artefacts of this term. - [ Design Controls ](/terms/design-controls) ### Replaced by Has been superseded by a newer term. - [ Quality Management System Regulation(QMSR) ](/terms/qmsr) ### Overlaps with Covers some of the same ground; not interchangeable. - [ ISO 13485 ](/terms/iso-13485) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Quality Management System Regulation(QMSR) FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. ](/terms/qmsr)[ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa)[ Quality & Risk Design Controls Structured process governing the design of medical devices. ](/terms/design-controls)[ Standards ISO 13485 International standard for medical device quality management systems. ](/terms/iso-13485) ### QMS Foundations · From this learning path [ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling?from=qms-foundations)[ Quality & Risk Design History File(DHF) Compilation of records describing the design history of a finished device. ](/terms/design-history-file?from=qms-foundations)[ Quality & Risk FDA Form 483 Notice of inspectional observations issued at the conclusion of an FDA inspection. ](/terms/form-483?from=qms-foundations)[ Quality & Risk Verification & Validation(V&V) Confirming design outputs meet inputs (V) and that devices meet user needs (V). ](/terms/verification-validation?from=qms-foundations) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [QMS Foundations](/paths/qms-foundations)Lesson 1 of 10 Ecosystems (2) - [Quality System](/ecosystems/quality-system) - [Global Markets](/ecosystems/global-markets) Comparisons (1) - [ISO 13485 vs 21 CFR 820 (QSR / QMSR)](/compare/iso-13485-vs-qsr)vs ISO 13485 ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 FDA· 1 ISO· 1 1. [1 Quality System Regulation (21 CFR 820) Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820) 2. [2 FDA - Quality Systems Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) 3. [3 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Tying cybersecurity into your QMS? We help align cybersecurity activities with ISO 13485 design controls and ISO 14971 risk management. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Quality & Risk Acronym QSR / 21 CFR 820 Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=qsr) Learn in 60 seconds Card Lesson Quiz FDA's current good manufacturing practice (cGMP) requirements for medical devices. - · 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. Remember this Watch out: Misinterpreting "harmonization" to mean identical, as there will still be FDA-specific requirements in the QMSR beyond ISO 13485:2016. Related terms - [ISO 13485 ](/terms/iso-13485) - [Corrective and Preventive Action(CAPA) ](/terms/capa) - [Design Controls ](/terms/design-controls) - [Quality Management System Regulation(QMSR) ](/terms/qmsr) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Device Master Record(DMR) ](/terms/dmr) - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [Change Control ](/terms/change-control) - [Design History File(DHF) ](/terms/design-history-file) - [Process FMEA vs Design FMEA(PFMEA / DFMEA) ](/terms/pfmea-vs-dfmea) - [Servicing (21 CFR 820.200) ](/terms/servicing) [All Quality & Risk terms](/terms?cat=Quality%20%26%20Risk) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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