FDA 21 CFR Part 820 Quality System Regulation: Definition, Requirements, and Key Changes

The FDA 21 CFR Part 820 Quality System Regulation (QSR) establishes current good manufacturing practice (cGMP) requirements for medical device manufacturers in the United States. FDA 21 CFR Part 820 ensures the safety, effectiveness, and quality of medical devices across their entire lifecycle.

Structured across 15 subparts, the FDA 21 CFR Part 820 regulation addresses critical quality processes such as design control, production, document management, process validation, and complaint handling.

Key provisions of FDA 21 CFR Part 820 include Design Controls (§820.30) to ensure safe and effective product design, and Document Controls (§820.40) for managing quality records. Other subparts of 21 CFR 820 include Subpart J (CAPA), which mandates the investigation and resolution of quality issues. Subpart M ensures traceable and audit-ready records like the Device Master Record (DMR) and Device History Record (DHR).

The FDA will implement the Quality Management System Regulation (QMSR), effective February 2, 2026, as part of regulatory modernization. The QMSR incorporates ISO 13485:2016 by reference and retires most original subparts C to O. However, FDA-specific oversight is preserved through newly introduced sections like §820.35 (Records) and §820.45 (Labeling).

To support compliance with FDA 21 CFR 820, medical device companies are increasingly adopting eQMS software.

Medical device QMS software, such as SimplerQMS, automates and integrates quality processes including CAPA, design controls, supplier management, and training tracking. SimplerQMS helps meet 21 CFR Part 820 requirements with audit-ready documentation, secure electronic signatures, version control, and more.

What Is the FDA 21 CFR Part 820 Quality System Regulation (QSR)?

The FDA 21 CFR Part 820 Quality System Regulation (QSR) is a set of regulations from the United States Food and Drug Administration (FDA) that emphasizes current good manufacturing practice (cGMP) requirements for medical device manufacturers. The FDA strictly enforces the QSR, which is codified under Title 21 of the Code of Federal Regulations (CFR), Part 820, and authorized by Section 520(f) of the Federal Food, Drug, and Cosmetic Act (FDCA).

The overall purpose of FDA 21 CFR Part 820 QSR is to ensure that medical devices marketed in the United States are safe, effective, and consistently produced throughout their lifecycle. FDA 21 CFR Part 820 QSR governs all stages of a device’s lifecycle, including design, manufacturing, packaging, labeling, storage, installation, and servicing.

FDA 21 CFR Part 820 QSR applies to various organizations, including medical device manufacturers, specification developers, contract manufacturers, packagers, re-labelers, and re-processors. Under specific conditions, FDA 21 CFR Part 820 QSR may also extend to importers and distributors.

The FDA 21 CFR Part 820 regulation covers Class I, II, and III medical devices and in vitro diagnostic (IVD) devices. Device classification differs from the EU MDR and EU IVDR, which use distinct classification systems. Classes I, IIa, IIb, and III are for medical devices under EU MDR, and Classes A to D are for IVDs under EU IVDR. The regulation may also apply to combination products when cGMP is the controlling requirement.

Compliance with FDA 21 CFR 820 QSR is non-negotiable for both domestic and foreign manufacturers seeking access to the U.S. market. Failure to comply can lead to severe regulatory actions such as warning letters, product recalls, seizures, import alerts, and civil or criminal penalties.

The FDA 21 CFR 820 QSR framework is built around core quality system elements, including management responsibility, design control, document control, production and process control, corrective and preventive actions (CAPA), and device history records (DHR). FDA 21 CFR 820 also requires maintaining a Design History File (DHF) to document design development and a Device Master Record (DMR) for production specifications. These components promote traceability, accountability, and continuous quality improvement.

To align with international standards and reduce regulatory duplication, the FDA has revised 21 CFR 820 QSR through an initiative called the Quality Management System Regulation (QMSR). This revision was finalized in February 2024 and will take effect on February 2, 2026. The QMSR harmonizes the framework with ISO 13485:2016, the globally recognized standard for medical device quality management systems (QMS).

FDA 21 CFR Part 820 retains specific U.S. requirements, such as Medical Device Reporting (MDR), which ISO 13485 does not fully address. As such, FDA 21 CFR 820 QSR remains a distinct and comprehensive quality system regulation that underpins FDA oversight of medical devices in the U.S. market.

What Is the Organizational Structure of the FDA 21 CFR 820 QSR?

The FDA 21 CFR Part 820 Quality System Regulation (QSR) is organized into 15 subparts, each corresponding to a key stage in the medical device lifecycle and core quality system processes. This modular QSR structure offers a logical, process-based framework for manufacturers to establish, implement, and maintain regulatory compliance across all operational areas.

The FDA 21 CFR Part 820 QSR begins with design and extends through production, labeling, packaging, distribution, and post-market service.

By aligning with the natural flow of a medical device’s lifecycle, the structure supports effective quality management and enables the FDA to conduct targeted inspections and audits. For manufacturers, it is a practical roadmap for developing procedures, maintaining documentation, performing gap analyses, and managing regulatory submissions.

Additionally, this structure facilitates CAPA investigations, reinforces system integrity, and helps ensure ongoing compliance with FDA expectations.

What Are the FDA 21 CFR Part 820 QSR Requirements?

The FDA 21 CFR Part 820 QSR requirements are listed below.

• 21 CFR Part 820 Subpart A—General Provisions: Defines the scope, applicability, and key terminology for manufacturers subject to FDA quality system regulations.
• 21 CFR Part 820 Subpart B—Quality System Requirements: Mandates executive responsibility for establishing and maintaining a compliant QMS.
• 21 CFR Part 820 Subpart C—Design Controls: Requires documented procedures to control the design and development of Class II and III medical devices and specific Class I devices not exempted by regulation.
• 21 CFR Part 820 Subpart D—Document Controls: Establishes requirements for approval, revision, and distribution of quality documents to ensure accuracy and control.
• 21 CFR Part 820 Subpart E—Purchasing Controls: Ensures evaluation, selection, and monitoring of suppliers and purchased products affecting device quality.
• 21 CFR Part 820 Subpart F—Identification and Traceability: Requires proper device identification and traceability throughout manufacturing and distribution processes.
• 21 CFR Part 820 Subpart G—Production and Process Controls: Regulates validated production methods, environmental conditions, and process parameters to ensure product quality.
• 21 CFR Part 820 Subpart H—Acceptance Activities: Requires inspections, testing, and acceptance criteria to confirm conformity of materials and finished devices.
• 21 CFR Part 820 Subpart I—Nonconforming Product: Establishes procedures for identifying, documenting, and properly disposing of defective or noncompliant products.
• 21 CFR Part 820 Subpart J—Corrective and Preventive Action: Requires systems to investigate quality issues, determine root causes, and implement CAPA measures.
• 21 CFR Part 820 Subpart K—Labeling and Packaging Control: Ensures labels and packaging are correctly approved, and prevents mix-ups or damage.
• 21 CFR Part 820 Subpart L—Handling, Storage, Distribution, and Installation: Specifies requirements to maintain product quality after manufacturing through to installation.
• 21 CFR Part 820 Subpart M—Records: Requires creation and maintenance of DMRs, DHRs, and QSRs to document compliance across the product lifecycle.
• 21 CFR Part 820 Subpart N—Servicing: Mandates procedures and recordkeeping for the servicing of medical devices and analysis of service data.
• 21 CFR Part 820 Subpart O—Statistical Techniques: Requires use of statistically valid techniques for quality data analysis, sampling plans, and process control.

21 CFR Part 820 Subpart A—General Provisions

Subpart A of FDA 21 CFR Part 820 establishes the foundational framework for the entire QSR. Subpart A defines the purpose, scope, and applicability of the regulation. It outlines the definitions of essential terms that inform compliance across all other subparts. 

Subpart A ensures consistent interpretation and implementation of quality requirements across all lifecycle stages, from design and manufacturing to post-market surveillance.

Subpart A applies to manufacturers of finished medical devices intended for human use in the U.S., including both domestic and foreign entities. Furthermore, Subpart A clarifies the relationship between Part 820 and other applicable FDA regulations. These include 21 CFR Part 801 (Labeling), Part 803 (Medical Device Reporting), Part 807 (Establishment Registration), and Part 11 (Electronic Records), where relevant.

The primary sections in Subpart A include the following.

• §820.1 Scope and Applicability: Establishes the scope of the QSR, clarifying which medical devices and manufacturers must comply with Part 820.
• §820.3 Definitions: Provides standardized definitions for key terms used throughout Part 820 to ensure consistent interpretation across the quality system.
• §820.5 Quality System: Requires manufacturers to implement and maintain a quality system appropriate for their device type and compliant with all QSR provisions.

Subpart A of 21 CFR Part 820 is rarely cited during FDA inspections, as it primarily contains general provisions. Subpart A guides the interpretation of the regulation rather than imposing specific operational requirements.

21 CFR Part 820 Subpart B—Quality System Requirements

Subpart B—Quality System Requirements of FDA 21 CFR Part 820 governs the core elements of a medical device manufacturer’s quality management infrastructure. Subpart B emphasizes management responsibility, internal audits, and personnel qualifications.

Subpart B applies across the entire product lifecycle, ensuring that quality management is integrated into design and production through post-market activities. Subpart B includes sections such as §820.20(b) Organizational Structure, §820.22 Quality Audits, and §820.25(b) Personnel Training.

Subpart B Section §820.20(b) Organizational Structure mandates that executive management establish a clear quality policy and objectives, supported by an appropriate organizational structure and resource allocation. Additionally, a management representative should be appointed to oversee the quality system.

Subpart B Section §820.20 Management Responsibility requirements are itemized below.

•  §820.20(a) Quality Policy: Establish, communicate, and maintain a quality policy and objectives, ensuring executive-level commitment is implemented throughout the organization.
• §820.20(b) Organization: Maintain a compliant organizational structure with defined roles and a qualified management representative responsible for QMS effectiveness and reporting to executive leadership.
• §820.20(c) Management Review: Conduct and document periodic reviews of the quality system to confirm its suitability and effectiveness against regulatory requirements and internal objectives.
• §820.20(d) Quality Planning: Develop and maintain a quality plan that defines applicable quality practices, resource allocations, and methods for meeting QSR requirements for each device.
• §820.20(e) Quality System Procedures: Establish documented quality system procedures and, where appropriate, provide a structured outline of the documentation used throughout the system.

Moreover, Section § 820.22 Quality Audit of Subpart B mandates that manufacturers conduct quality audits using independent personnel to assess system effectiveness and regulatory compliance.

Section § 820.25 Personnel is divided into subsections a and b. The details for each are below.

• § 820.25(a) General: Maintain sufficient personnel with appropriate qualifications, education, and experience to perform all QSR-required activities correctly.
• § 820.25(b) Training: Establish and document training procedures that identify needs and ensure personnel are competent.

Section § 820.25 requires medical device companies to ensure that personnel are qualified through appropriate education, training, and experience, and maintain documented training procedures. Additional expectations include conducting management reviews, implementing quality planning, and establishing formal quality system procedures.

For instance, from 2008 to 2025, FDA inspectors issued over 1,070 citations during inspections to medical device companies for inadequate procedures, lack of defined intervals, or insufficient frequency of management reviews, according to the U.S. FDA Data Dashboard (exported May 5, 2025). This scenario highlights persistent compliance gaps in fulfilling the management responsibility requirements under 21 CFR Part 820, Subpart B.

21 CFR Part 820 Subpart C—Design Controls

Subpart C – Design Controls of FDA 21 CFR Part 820 governs the structured requirements for designing and developing Class II and III medical devices and selected Class I medical devices.

Subpart C ensures that device design is carefully controlled and systematically translated into a product that meets defined user needs, intended uses, and performance specifications.

Applicable during the design and development phase of the device lifecycle, Subpart C requires manufacturers to implement detailed processes. These processes include design planning, input and output documentation, risk management, and design review. Other processes include design verification, design validation, and the maintenance of a design history file (DHF).

Section § 820.30 Design controls include the following subsections.

• §820.30(a) General: Apply design control requirements to the design and development of Class II and III devices, and selected Class I devices, to ensure safety, effectiveness, and regulatory compliance.
• §820.30(b) Design and Development Planning: Establish and maintain design plans that define tasks, responsibilities, and interactions across development functions.
• §820.30(c) Design Input: Define and document input requirements based on user needs and applicable regulatory criteria, ensuring clarity and completeness.
• §820.30(d) Design Output: Generate and approve outputs that align with design inputs and provide a basis for safe, effective device production.
• §820.30(e) Design Review: Conduct formal, documented reviews at key development stages to evaluate adequacy, resolve issues, and support decision-making.
• §820.30(f) Design Verification: Verify that outputs meet inputs by using objective, documented evidence to confirm conformance.
• §820.30(g) Design Validation: Validate the final product under real or simulated conditions to ensure it fulfills intended use and user expectations.
• §820.30(h) Design Transfer: Control the transfer of design information to production to ensure the implementation of accurate, approved specifications.
• §820.30(i) Design Change: Control and document all design changes throughout the device lifecycle to preserve design integrity and compliance.
• §820.30(j) Design History File (DHF): Maintain a DHF that includes all records showing the device design process followed established procedures and regulatory requirements.

According to the U.S. FDA Data Dashboard (exported May 5, 2025), from 2008 to 2025, FDA inspectors issued 5,740 citations to medical device companies under 21 CFR 820.30(a–j), which governs Design Controls. Among these, §820.30(g) – Design Validation accounted for the highest number of violations, totaling 1,855 citations. The most common issues cited included failure to perform risk analysis, lack of or inadequate design control procedures, and failure to validate software used in production or quality systems.

21 CFR Part 820 Subpart D—Document Controls

Subpart D – Document Controls of FDA 21 CFR Part 820 outlines the requirements for establishing and maintaining control over all quality system documents used in the manufacture of medical devices.

Subpart D is pivotal in promoting traceability, consistency, and accountability, and is often closely scrutinized during FDA inspections, particularly in connection with design history files (DHF), device master records (DMR), and CAPA documentation.

Subpart D applies across all phases of the medical device lifecycle, ensuring that documentation critical to design, production, testing, labeling, servicing, and regulatory compliance is accurate, approved, accessible, and up to date.

Manufacturers are required to implement procedures for document approval, distribution, change control, and retention. Each document must be reviewed and approved by designated personnel before issuance, and obsolete/retired documents must be promptly removed from points of use to prevent errors. Document changes must be identified, tracked, and justified, and they must be reviewed and approved in the same manner as the original documents.

Subpart D Section § 820.40 Document controls are listed and described below.

• §820.40(a) Document Approval and Distribution: Review, approval, and document quality system records before release, ensuring availability at points of use and timely removal of obsolete versions.
• §820.40(b) Document Changes: Control and document change through formal review and approval, including effective date, approver identification, and change communication.

Compliance with Subpart D – Document Controls is critically scrutinized during FDA inspections.

According to the U.S. FDA Data Dashboard (exported May 5, 2025), between 2008 and 2025, medical device companies received 1,556 citations under §820.40(a–b), highlighting persistent challenges in maintaining compliant document control systems. The most frequently cited issues involved failure to establish, inadequately defined, or poorly maintained document control procedures.

21 CFR Part 820 Subpart E—Purchasing Controls

FDA 21 CFR Part 820 Subpart E – Purchasing Controls establishes requirements for evaluating, selecting, and controlling suppliers, contractors, and consultants. These parties provide products or services that affect the quality of medical devices.

Subpart E ensures that purchased materials, components, and services conform to specified requirements before they are incorporated into the medical device.

Manufacturers must implement documented procedures to assess and approve suppliers based on their ability to meet defined quality criteria and maintain supplier evaluations and re-evaluation records. Purchasing data must clearly describe the product specifications, quality requirements, and any additional conditions necessary to ensure compliance.

Section § 820.50 Purchasing Controls included in Subpart E are itemized below.

• §820.50(a) Evaluation of Suppliers, Contractors, Consultants: Define, evaluate, and document supplier requirements based on their ability to meet quality specifications, and maintain control records and approved supplier lists.
• §820.50(b) Purchasing Data: Establish purchasing documentation that clearly states quality requirements and includes agreements for change notification, approved per §820.40.

Subpart E—Purchasing Controls remains a frequent focus during FDA inspections, with 3,011 citations issued to medical device companies between 2008 and 2025, according to the U.S. FDA Data Dashboard (exported May 5, 2025). The most cited section was §820.50. The leading cause of these citations was the absence of documented procedures or inadequate purchasing controls.

21 CFR Part 820 Subpart F—Identification and Traceability

FDA 21 CFR Part 820 Subpart F – Identification and Traceability sets forth the requirements for ensuring that medical devices and their components are identified and traceable throughout manufacturing and distribution.

Subpart F is critical in enabling product accountability, minimizing the risk of mix-ups or mislabeling, and ensuring patient safety, particularly when device failures or adverse events must be investigated and addressed swiftly.

The sections included in Subpart F are itemized below.

• §820.60 Product Identification: Establish and apply procedures to identify products throughout all stages of receipt, manufacturing, distribution, and installation to prevent mix-ups.
• §820.65 Traceability: Implement traceability procedures using control numbers for implantable or life-supporting devices to enable corrective actions and ensure DHR documentation.

Manufacturers must implement procedures to identify products during all stages of receipt, production, packaging, and distribution, using appropriate labels, barcodes, or other tracking mechanisms. This identification enables effective segregation of nonconforming materials and supports the integrity of manufacturing processes.

For certain devices intended for surgical implantation, the regulation also requires a traceability system that links each finished device to its components, manufacturing history, and distribution records, including lot or serial numbers. These records are essential for corrective action, field alerts, or recalls.

Between 2008 and 2025, FDA inspectors issued 113 citations under §820.60 for inadequate or missing procedures for product identification according to the U.S. FDA Data Dashboard (exported May 5, 2025). Additionally, §820.65, which requires traceability of medical devices, accounted for six (6) citations, primarily due to the lack of proper traceability system procedures.

21 CFR Part 820 Subpart G—Production and Process Controls

Subpart G – Production and Process Controls of FDA 21 CFR Part 820 defines requirements for controlling manufacturing processes to ensure consistent compliance with device specifications.

Subpart G ensures repeatability, minimizes variability and protects product quality and safety across production batches.

Manufacturers must establish and follow documented procedures for production methods, process monitoring, and quality assurance activities. These procedures must ensure that the equipment is properly maintained, calibrated, and validated. Production environments must be controlled to prevent contamination or damage, particularly for sterile or sensitive devices.

Subpart G requires that production personnel be qualified and trained and that manufacturing instructions and specifications be clear, complete, and accessible at the point of use. When process results cannot be fully verified by inspection or testing, manufacturers must validate processes to demonstrate consistent production of conforming products.

Section § 820.70 Production and Process Controls focuses on developing, documenting, and controlling production processes to ensure medical devices meet specifications.

§ 820.70 Production and process controls include the subsections listed below.

• § 820.70(a) General: Develop, conduct, control, and monitor production processes using documented procedures and controls to ensure product conformance to specifications.
• § 820.70(b) Production and Process Changes: Control and document changes to specifications, processes, or methods, and verify or validate such changes before implementation in accordance with § 820.75 and § 820.40.
• § 820.70(c) Environmental Control: Implement procedures to control environmental conditions that could affect product quality and periodically inspect and document the condition of environmental control systems.
• § 820.70(d) Personnel: Maintain hygiene, cleanliness, and personal conduct guidelines for staff in critical areas, and ensure temporary personnel are trained or supervised when operating in special environments.
• § 820.70(e) Contamination Control: Establish controls to prevent contamination of equipment or products by substances that could impact product quality.
• § 820.70(f) Buildings: Design and maintain facilities with sufficient space and logical layout to prevent mix-ups and ensure orderly material flow.
• § 820.70(g) Equipment: Ensure manufacturing equipment is designed, installed, and maintained for effective cleaning, adjustment, and compliance with production requirements.
• § 820.70(h) Manufacturing Material: Control and document the use and removal of materials that could adversely affect product quality to ensure their levels are safe or eliminated.
• § 820.70(i) Automated Processes: Validate and document software used in production or the QMS to ensure intended performance, including validation of software changes before use.

Subpart G Section § 820.72 Inspection, Measuring, and Test Equipment has subsections listed below.

• § 820.72(a) Equipment Control: Ensure inspection, measuring, and test equipment is suitable for its intended purpose. Implement procedures for routine calibration, inspection, handling, and storage to maintain accuracy, with documentation of all activities.
• § 820.72(b) Calibration: Define calibration procedures with clear accuracy and precision limits, and require corrective action if limits are exceeded.

Validate, monitor, and revalidate processes where output cannot be fully verified, ensuring consistency, qualified personnel, and documented approvals.

Subpart G Section § 820.75 Process Validation has subsections from a to c and is listed below.

• 820.75(a) Initial Validation: Validate and approve processes that cannot be fully verified through inspection or testing, and document results with approver signatures and equipment details.
• 820.75(b) Monitoring Validated Processes: Establish procedures to monitor and control validated process parameters and ensure they are consistently performed by qualified personnel, with full documentation.
• 820.75(c) Revalidation: Review, evaluate, and revalidate processes when changes or deviations occur, and document all outcomes to maintain compliance.

Subpart G – Production and Process Controls is a consistent focus during FDA inspections, particularly in cases where lapses in manufacturing controls have contributed to product nonconformities or recalls. From 2008 to 2025, the FDA issued 2,682 citations under §820.70, underscoring the high risk of noncompliance in this area according to the U.S. FDA Data Dashboard (exported May 5, 2025). The most frequently cited section was §820.70(a), primarily due to a lack of or poorly defined procedures.

21 CFR Part 820 Subpart H—Acceptance Activities

FDA 21 CFR Part 820 Subpart H – Acceptance Activities establishes inspection, testing, and acceptance procedures requirements to confirm that incoming materials, in-process products, and finished devices meet specified criteria.

Subpart H supports traceability and quality assurance by preventing defective products from reaching patients.

Manufacturers must develop and maintain procedures to inspect and test products at key stages, such as upon receipt, during manufacturing, and after final assembly. These procedures ensure that products conform to approved specifications before proceeding or being released for distribution.

All results from acceptance activities must be documented. Only products that meet inspection criteria may advance or be distributed. Acceptance status must be clearly indicated through labels, records, or physical segregation. This practice is to prevent the use of unapproved or nonconforming materials.

Section § 820.80 Receiving, In-process, and Finished Device Acceptance mandates that procedures be established and documented to inspect, verify, control, and approve products at the receiving, in-process, and final stages.

Section § 820.80 Receiving, In-process, and Finished Device Acceptance requirements are itemized in the list below.

• § 820.80(a) General: Establish and maintain procedures for acceptance activities such as inspections, tests, and verifications to confirm product conformity.
• § 820.80(b) Receiving Acceptance Activities: Inspect, test, or verify incoming materials against specified requirements and document acceptance or rejection results.
• § 820.80(c) In-Process Acceptance Activities: Control in-process product until inspection, testing, or verification confirms it meets requirements, and document all activities.
• § 820.80(d) Final Acceptance Activities: Hold finished devices under control until DMR activities are completed, data reviewed, and release is formally authorized and dated.
• § 820.80(e) Acceptance Records: Document all acceptance activities with details including actions performed, dates, results, signatures, and equipment used as part of the DHR.

Another section under Subpart H is § 820.86 Acceptance status. This requirement mainly focuses on identifying and maintaining the acceptance status of products throughout the medical device lifecycle to ensure that only accepted items proceed to distribution or use.

According to the U.S. FDA Data Dashboard (exported May 5, 2025), no FDA citations were issued under this requirement from 2008 to 2025, indicating that medical device manufacturers consistently meet expectations in this area.

21 CFR Part 820 Subpart I—Nonconforming Product

21 CFR Part 820 Subpart I – Nonconforming Product governs the requirements for identifying, documenting, evaluating, and controlling products that fail to meet specified requirements.

Subpart I is crucial for maintaining product integrity and, in turn, protecting patients. Subpart I ensures that nonconforming products are systematically managed to prevent defects from compromising safety or performance.

Subpart I Section § 820.90 Nonconforming product includes the subsections itemized below.

• § 820.90(a) Control of Nonconforming Product: Establish procedures to identify, evaluate, document, segregate, and disposition nonconforming products.
• § 820.90(b)(1) Nonconformity Review and Disposition: Define the authority and responsibilities for reviewing and disposing of nonconforming products, and document justification and approvals for any use of such products.
• § 820.90(b)(2) Rework and Reevaluation: Create procedures for reworking nonconforming products, including retesting and impact assessment, and ensure all rework activities are fully documented in the DHR.

Each non-conformance must be evaluated to determine its cause and impact. Manufacturers must decide whether to rework, reprocess, scrap, or release the product under concession, with decisions documented and justified. When rework is performed, the manufacturer must follow documented procedures and re-verify that the product meets original specifications. If rework could affect product quality, the process must be validated.

Just like Subpart H, Subpart I had no FDA citations issued under this requirement from 2008 to 2025, according to the U.S. FDA Data Dashboard (exported May 5, 2025). This scenario indicates that medical device manufacturers consistently meet expectations in this area.

21 CFR Part 820 Subpart J—Corrective and Preventive Action

Subpart J—Corrective and Preventive Action (CAPA) of 21 CFR Part 820 requires manufacturers to establish and maintain procedures to identify, investigate, solve, and prevent issues from recurrence.

Subpart J is central to the FDA’s quality system regulation because it drives continuous improvement and risk mitigation.

The only section in Subpart J is Section § 820.100 Corrective and Preventive Action, which mandates that each manufacturer establish and maintain CAPA procedures.

Subsections of § 820.100 Corrective and Preventive Action are listed below.

• § 820.100(a) CAPA Procedures: Establish and maintain CAPA procedures to identify, address, and prevent quality problems and nonconformities through systematic analysis and action.
• § 820.100(a1) Analyze Quality Data: Analyze all relevant data sources using statistical tools where needed to detect existing and potential quality issues.
• § 820.100(a2) Investigate Nonconformities: Investigate root causes of product, process, or system nonconformities.
• § 820.100(a3) Identify Actions: Determine corrective and preventive actions necessary to eliminate and prevent recurrence of identified problems.
• § 820.100(a4) Verify or Validate Actions: Verify or validate the effectiveness of actions to ensure they resolve the issue without introducing new risks.
• § 820.100(a5) Implement and Record Changes: Apply and document updates to methods or procedures that are needed to correct and prevent issues.
• § 820.100(a6) Disseminate Quality Information: Communicate quality problem information to personnel responsible for maintaining or improving product quality.
• § 820.100(a7) Management Review: Submit CAPA information to management for periodic review and oversight of systemic issues and resolutions.
• § 820.100(b) Documentation: Document all CAPA activities and results to ensure traceability, accountability, and compliance within the quality system.

CAPA systems must detect actual or potential nonconformities through sources such as complaints, audit findings, service records, or production trends. Manufacturers must analyze data to identify the root cause of problems. Once identified, appropriate corrective or preventive actions must be implemented. These actions must be documented, verified, validated, and monitored for effectiveness. Product design or process changes must be reviewed under the change control and validation framework.

Deficiencies in CAPA systems are among the most cited violations in FDA inspections, often due to a lack of and inadequate procedures, incomplete documentation, or weak investigations. According to the U.S. FDA Data Dashboard (exported May 5, 2025), from 2008 to 2025, the FDA issued 5,783 citations, with §820.100(a) alone accounting for 4,085 of these citations. This data suggests that many organizations struggle to implement effective systems for identifying, documenting, and resolving issues.

21 CFR Part 820 Subpart K—Labeling and Packaging Control

Subpart K – Labeling and Packaging Control of 21 CFR Part 820 outlines the requirements for ensuring that labeling and packaging materials are accurate, traceable, and properly managed throughout the production process.

Subpart K plays a vital role in preventing user errors, regulatory violations, and product recalls due to mislabeling or inadequate packaging.

The key requirements of Section § 820.120 Device labeling under Subpart K are itemized below.

• § 820.120(a) Label Integrity: Ensure labeling is legible and securely affixed during storage and distribution to maintain identification and prevent detachment.
• § 820.120(b) Label Inspection: Inspect labels for accuracy, including correct expiration date, control number, and device identification, before release.
• § 820.120(c) Label Storage: Store labeling materials in a controlled manner to prevent mixups, damage, or misidentification.
• § 820.120(d) Labeling Operations Control: Implement procedures to prevent label errors during application, including safeguards against mixups.
• § 820.120(e) Labeling Documentation: Document label inspection and application activities in the DHR, including dates and responsible individuals.

Manufacturers must develop procedures to control labeling content, integrity, storage, issuance, and application. These controls are essential to prevent mix-ups, mislabeling, and damage that could compromise device identity or safety.

Labels must be legible, permanently affixed where required, and comply with applicable regulatory requirements. Each label must be verified for accuracy before release. The labeling process must include documentation of label content, version control, and the use of correct labels for each product configuration.

Moreover, Section § 820.130 Device Packaging under Subpart K mandatescontrolling packaging processes to ensure that materials are suitable and protective and prevent damage or contamination during handling, storage, and shipping.

For instance, between 2008 and 2025, the FDA issued 450 citations under this subpart, primarily due to a lack of or inadequate labeling procedures according to the U.S. FDA Data Dashboard (exported May 5, 2025). These citations typically reflect failures to ensure that labels are properly applied, legible, and accurate, or that packaging controls are sufficient to prevent mislabeling or product damage. Maintaining robust labeling procedures is essential for preventing distribution errors and ensuring product integrity in accordance with 21 CFR Part 820.

21 CFR Part 820 Subpart L—Handling, Storage, Distribution, and Installation

21 CFR Part 820 Subpart L – Handling, Storage, Distribution, and Installation establishes requirements to protect medical devices from damage, contamination, and deterioration throughout post-production processes.

Subpart L is essential to maintaining medical device quality beyond manufacturing.

The sections for Subpart L are listed below.

• § 820.140 Handling: Establish procedures for handling products throughout the production lifecycle to prevent damage, deterioration, contamination, or mix-ups.
• § 820.150(a) Storage Area Control: Establish and maintain procedures to prevent product mix-ups, deterioration, or contamination, and control stock rotation for items with limited shelf life.
• § 820.150(b) Storage Authorization: Define procedures for controlling the movement of products in and out of storage areas, including receipt and dispatch authorization.
• § 820.160(a) Distribution Controls: Ensure only approved devices are distributed by establishing procedures that include purchase order review and controls for product expiration or deterioration.
• § 820.160(b) Distribution Records: Maintain distribution records documenting the consignee’s name, device identification and quantity, shipping date, and control numbers.
• § 820.170(a) Installation Instructions: Develop and provide installation procedures that include inspection and testing steps to ensure the device performs as intended post-installation.
• § 820.170(b) Installation Execution and Documentation: Require installers to follow procedures and document installation, inspections, and test results to verify proper device setup.

Manufacturers must implement procedures to handle and store devices in controlled conditions that maintain product integrity until final use.

Handling procedures must prevent physical damage or degradation. Storage areas must be designed and maintained to protect products, with clear controls for stock rotation and expiration management where applicable.

Medical devices must only be distributed after final inspection and acceptance. Distribution records must ensure traceability, showing that products were shipped according to the approved procedures and to the intended recipients.

Manufacturers must provide documented instructions and, where applicable, qualified personnel must perform or oversee the installation if required. Proper installation ensures the device functions safely and effectively in its operational environment.

According to the U.S. FDA Data Dashboard (exported May 5, 2025), from 2008 to 2025, FDA inspections resulted in 48 citations under §820.140. Reasons are mainly due to a lack of or inadequate handling procedures, emphasizing the need for defined processes to prevent product damage or contamination. Furthermore, §820.150 accounted for 162 citations while §820.160 had 127 FDA citations.

21 CFR Part 820 Subpart M—Records

21 CFR Part 820 Subpart M – Records requires manufacturers to establish and maintain documentation demonstrating compliance with all QSR aspects. Records must be accurate, readily retrievable, and safeguarded against alteration, loss, or unauthorized access. They must be legible, identifiable, and maintained in a format that permits timely review by internal teams and FDA inspectors.

Subpart M allows electronic records under certain conditions, aligning with 21 CFR Part 11 for electronic signatures and data integrity. Proper recordkeeping is critical to traceability, accountability, and regulatory defense.

The sections for Subpart M are listed below.

• § 820.180 General Requirements (a–c): Establish, retain, and make available quality system records, including procedures, data, and results, while limiting access only as permitted by regulation.
• § 820.181 Device Master Record (a–e): Maintain a complete Device Master Record (DMR) that includes specifications, production processes, labeling, packaging, and quality procedures for each device type.
• § 820.184 Device History Record (a–f): Compile and retain a Device History Record (DHR) for each batch or unit to demonstrate that it was manufactured according to the DMR and regulatory requirements.
• § 820.186 Quality System Record: Maintain a Quality System Record (QSR) that includes all quality system procedures and documentation not specific to a particular device.
• § 820.198 Complaint Files (a–g): Establish complaint handling procedures, evaluate and investigate complaints, determine reportability, and document findings, corrective actions, and communication.

This subpart includes specific types of records such as the Device Master Record (DMR), Device History Record (DHR), and Quality System Record (QSR). The DMR defines product specifications and manufacturing processes. The DHR documents production history for each batch or unit, verifying that it was made and tested according to the DMR. The QSR contains procedures and records necessary to demonstrate overall system compliance.

Between 2008 and 2025, the FDA issued 114 citations under §820.180 for general recordkeeping deficiencies. The FDA issued 866 citations under §820.181 due to DMRs not being established or adequately maintained. Most notably, §820.184, in which DHRs accounted for 1,855 citations, with violations often stemming from incomplete or missing production records.

21 CFR Part 820 Subpart N—Servicing

Subpart N – Servicing of 21 CFR Part 820 applies to medical devices that require routine or corrective maintenance after distribution.

Subpart N ensures post-market functionality and safety, especially for devices used in critical care or long-term applications. Failures in servicing control can lead to patient risk, product recalls, or enforcement actions due to noncompliance or undetected performance degradation.

Requirements of Section § 820.200 Servicing (a-d) are listed below.

• 820.200(a) Servicing Procedures: Establish and maintain servicing procedures for medical devices where servicing is specified as part of the manufacturer’s QMS.
• 820.200(b) Service Reports: Document all service activities, including the date, the individual performing the service, and device identification.
• 820.200(c) Failure Analysis: Analyze service reports for trends or issues that may indicate nonconformities or the need for corrective action.
• 820.200(d) Reporting Requirements: Submit Medical Device Reports (MDRs) if servicing activities reveal reportable events under §803.

Manufacturers must establish and maintain documented procedures for performing and verifying servicing activities. Manufacturers are required to maintain records of all servicing activities. These records must include device identification, service dates, performed actions, test and inspection results, and the individual performing the service. Manufacturers must evaluate whether a CAPA is necessary under Subpart J if service reports indicate recurring issues or systemic problems.

According to the U.S. FDA Data Dashboard (exported May 5, 2025), Subpart N has no FDA citations issued from 2008 to 2025. This indicates that medical device manufacturers consistently meet expectations in this area.

21 CFR Part 820 Subpart O—Statistical Techniques

21 CFR Part 820 Subpart O – Statistical Techniques requires manufacturers to use appropriate statistical methods to establish, control, and verify product characteristics’ acceptability and process performance.

Subpart O ensures that quality decision-making is data-driven, objective, and defensible. Improper use or absence of statistical techniques can lead to incorrect acceptance of nonconforming products, process instability, or undetected deviations.

Subpart O Section § 820.250 Statistical techniques requirements are listed below.

• § 820.250(a) Application of Statistical Methods: Identify and apply appropriate statistical techniques to verify process capability, product acceptability, and QMS effectiveness.
• § 820.250(b) Sampling Plans: Establish, validate, and document sampling plans using valid statistical rationale to ensure they are adequate for their intended purpose.

Manufacturers must define when statistical methods are needed and correctly apply them during design, production, and quality assurance activities. Procedures must include statistical sampling plans that are based on valid scientific rationale. These plans must ensure that samples are representative and that acceptance criteria are clearly defined. Statistical tools may be applied in areas such as incoming material inspection, process validation, product testing, and trend analysis.

From 2008 to 2025, the FDA issued a total of 481 citations under this subpart, reflecting gaps in how medical device manufacturers use and document statistical tools. Of these, §820.250(b), which pertains to sampling plans, accounted for 314 citations, including 215 for inadequately defined sampling plans and 95 for lacking proper procedures. An additional two (2) citations were issued for failing to review sampling methods for adequacy.

Under §820.250(a), which governs broader statistical techniques, 167 citations were issued according to the U.S. FDA Data Dashboard (exported May 5, 2025). 157 of these were due to the absence of or inadequate statistical procedures, while others stemmed from inappropriate or unvalidated techniques. These findings highlight the critical role of statistically sound methods in ensuring process control, product quality, and regulatory compliance.

What Are the Key Changes to the 21 CFR Part 820 QSR?

The key changes to the 21 CFR Part 820 QSR are shown in the table below.

Category	New Change(s)	Detail(s) Replaced
New Regulation Name	Quality Management System Regulation (QMSR)	Replaces the title “Quality System Regulation”
Core Standard Adopted	ISO 13485:2016 (incorporated by reference)	Replaces most of the Subparts of the original QSR
Structural Changes	ISO 13485:2016 structure adopted as the primary framework	Subparts A-B retained, but original Subparts C–O were reserved from QSR
Added Sections	§820.1: Scope §820.1: Definitions §820.7: Incorporation by Reference §820.10: Requirements for a Quality System §820.35: Records §820.45: Device Labeling and Packaging	Adds FDA-specific content not covered by ISO
Definitions	Adopted from ISO 13485:2016 and ISO 9000:2015	Supersedes prior QSR-specific definitions under §820.3

The transition from the QSR to the QMSR marks a pivotal step in the FDA’s initiative to align U.S. medical device regulations with international standards, particularly ISO 13485:2016. This harmonization reduces regulatory fragmentation, easing the compliance burden for manufacturers operating across multiple jurisdictions and enabling more efficient global market access.

Key structural changes include the withdrawal of Subparts C through O of the original QSR and the Incorporation by Reference (IBR) of ISO 13485:2016 as the foundational quality standard.

New U.S.-specific provisions, such as those covering record control and labeling, have been introduced to maintain essential FDA oversight, creating a globally harmonized yet domestically responsive framework. The QMSR aims to eliminate duplicative audits, streamline documentation, and foster regulatory convergence with authorities in the EU, Canada, Japan, and other markets.

While ISO 13485-certified manufacturers will be better positioned under the QMSR, they must still meet FDA-specific obligations, including UDI compliance and reporting obligations. Importantly, FDA inspections will remain mandatory regardless of ISO certification status.

The Final Rule was issued on February 2, 2024, and will be effective on February 2, 2026, allowing a two-year transition period. The original 21 CFR 820 will remain in effect until the transition ends. Manufacturers are encouraged to conduct gap assessments, revise documentation, and update quality processes to meet the new QMSR expectations and ensure uninterrupted regulatory compliance.

What Is the Difference Between FDA 21 CFR Part 820 and ISO 13485:2016?

The primary difference between FDA 21 CFR Part 820 and ISO 13485:2016 lies in their legal authority and geographic scope.

21 CFR Part 820 is a federally enforceable U.S. regulation issued and enforced by the FDA.  21 CFR Part 820 mandates cGMP for medical device manufacturers seeking market access in the United States.

In contrast, ISO 13485:2016 is an international voluntary standard, published by the International Organization for Standardization (ISO). ISO 13485:2016 outlines QMS requirements for medical device lifecycle activities.

While compliance with 21 CFR Part 820 is mandatory for manufacturers distributing in the U.S., adherence to ISO 13485 is voluntary unless adopted into national regulations. However, this is changing with the FDA’s regulatory update in 2024, known as the QMSR. Effective February 2, 2026, the QMSR will incorporate ISO 13485:2016 by reference as the U.S. QMS baseline, while preserving U.S.-specific requirements.

As such, certification to ISO 13485 alone will not be sufficient; manufacturers must also comply with additional QMSR-specific expectations to meet full FDA requirements.

How Does Medical Device QMS Software Support 21 CFR Part 820 Compliance?

Medical device QMS software plays a critical role in supporting compliance with FDA 21 CFR Part 820 by automating, standardizing, and documenting the quality processes required under the QSR. An electronic QMS enables medical device manufacturers to implement and maintain a fully traceable, audit-ready, and regulation-compliant framework.

Medical device eQMS solutions help manage essential QSR requirements such as document control, change management, CAPA, design controls, training, complaint handling, and more. These capabilities directly align with key subparts of 21 CFR Part 820, including Subpart D (Document Controls), Subpart J (Corrective and Preventive Action), Subpart C (Design Controls), and Subpart M (Records).

SimplerQMS is designed to support compliance with both FDA 21 CFR Part 820 and ISO 13485:2016. SimplerQMS provides comprehensive QMS modules for risk management, supplier management, CAPA management, and more. SimplerQMS is a system fully validated according to GAMP 5 and complies with 21 CFR Part 11 and EU GMP Annex 11, ensuring secure electronic signatures, version control, and audit trails.