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QMSR Definitions and Vocabulary

Learn about definition changes between QSR and QMSR

QMSR Definitions

The transition to the FDA’s new Quality Management System Regulation (QMSR) brings updated terminology and definitions that are crucial for ensuring compliance. Whether you’re new to regulatory requirements or transitioning from the Quality System Regulation (QSR), understanding the key vocabulary is essential for building an effective quality management system.

This page provides a comprehensive list of definitions and terms used in the QMSR, including updated terminology like the Design and Development File (DDF), Medical Device File (MDF), and Device Batch Record. By aligning with ISO 13485 standards, the QMSR introduces language and concepts designed to harmonize U.S. and international quality requirements.

In determining the definitions that will apply to the QMSR, the Food and Drug Administration (FDA) had to consider terms in ISO 13485, ISO 9000 Clause 3, and the current Quality System Regulation (QSR). And on top of that, the agency had to make sure that there were no conflicts in meaning or terminology with the definitions in the federal Food, Drug, and Cosmetics Act (FD&C Act). 

The result was that most of the definitions came from the two ISO standards, and the rest were retained in the new 21 CFR 820.3 QMSR. Those retained in the QMSR were either terms that were covered in the FD&C Act or were otherwise specific to the mission of the FDA.  Also, the QMSR and ISO 13485 recognize that there may be local jurisdictional definitions or more device-specific information (e.g. Special Controls) that could supersede those listed in the QMSR. 

Some terms were deemed to be equivalent between the regulation and standards, some QSR terms were changed to match those in ISO 13485, and the remaining QSR definitions were dropped. We recommend that you read the QMSR Final Rule to develop a better understanding from a good discussion that explains FDA’s reasoning behind the final QMSR definitions. 

Explore these definitions to ensure you’re equipped with the knowledge needed to navigate the QMSR framework with confidence and clarity.

Also – this page is a work in progress. I will be adding more definitions and information.

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FDA terms that are not addressed in either of the ISO standards and are listed in 820.3 of the QMSR: 

  • Component – unchanged from the QSR. FDA stresses the distinction between components and finished devices, to make sure these terms are clear; a finished device is not necessarily one that is in its final form. For example, if a sterile device has not been packaged or sterilized but is otherwise capable of functioning, it is considered to be a finished device. 
  • Federal Food, Drug, and Cosmetic Act 
  • Finished device 
  • Human cell, tissue, or cellular or tissue-based product (HCT/P) 
  • Remanufacturer 

FD&C terms that supersede those in ISO 13485 and ISO 9000 and are listed in 820.3 of the QMSR.  

Note:  the definitions are in Part 201 of the Act, but when codified into U.S. Code they became 21 U.S.C. § 321. 

  • Implantable medical device – which has the same meaning as “implant” in 820.3 
  • Manufacturer 
  • Organization – has the meaning of “manufacturer” to align with ISO 13485 
  • Rework – FDA is using its own definition of this in 820.3 rather than the one in ISO 9000, because the latter considers rework to apply to product that has not been released for distribution and product that has been released. FDA stresses that its definition of rework applies only to devices that have not been released, and actions taken to resolve a nonconformance after the product has been released shall not be considered to be rework. 
  • Safety and Performance – which has the same meaning as “safe and effective,” but only within Clause 0.1 of ISO 13485. 
  • Batch, or lot – The terms are used in ISO 13485 but not defined, so they will be retained; FDA says they are in 820.3, but I don’t see them? They are listed in the current QSR 820.3(m) – Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. The term will be used as the replacement for Device History Record (DHR) which under the MSDR will become the Lot Record or Batch Record. 

Current QSR definitions that will be dropped or replaced with ISO definitions 

  • Design History File (DHF) will be replaced by the ISO 13485 term “Design and Development File (DDF).” 
  • Device History Record (DHR) will be replaced by the ISO 13485 term “Lot Record,” or “Batch Record.” 
  • The term “establish” will not be used in the QMSR. Its QSR definition included the meaning “to define, document, and implement.” Although the definitions are not exactly the same, establish will be replaced by ISO 13485’s term “document.” And FDA points out that the ISO 13485 definition includes the actions of establishing, implementing, and maintaining, and that keeping establish would be redundant. 
  • Management with executive responsibility – replaced by ISO 9000 term “top management.” Although the term will change, FDA continues to expect that device manufacturers led by individuals with executive responsibility to embrace a culture of quality as a key component in ensuring the production of safe and effective medical devices 
  • Medical Device Record (MDR) will be replaced by the ISO 13485 term “Medical Device File (MDF).” 
  • “Obsolete product” (from 820.50) will be dropped. See the Final Rule for the justification. 
  • The definition of “product” in the QSR is different from that in ISO 13485, and FDA will use the ISO definition. FDA considers the definition to include, but is not limited to: components, in-process devices, finished devices, services, and returned devices. 
  • “Special process” will no longer be used 

Definitions Incorporated by Reference: 

The QMSR incorporates definitions from ISO 13485:2016 and Clause 3 of ISO 9000:2015, except where specified otherwise. This incorporation aims to harmonize terminology and reduce discrepancies between U.S. regulations and international standards.

Hierarchy of Definitions:

The hierarchy for definitions under the QMSR is as follows: 

  • FD&C Act Section 201: Definitions here apply universally and supersede others. 
  • 21 CFR 820.3: Provides additional definitions specific to the QMSR. 
  • ISO 13485:2016 and ISO 9000:2015 Clause 3: Incorporated by reference, except where overridden by the above. 

This structured approach ensures clarity and consistency in terminology, facilitating compliance and understanding across different regulatory frameworks. 

For a comprehensive list of definitions and detailed information, refer to the FDA’s Final Rule for the Quality Management System Regulation. 

ISO 13485 Definitions 

  • Advisory notice 
  • Authorized representative – this is an EU term 
  • Clinical evaluation 
  • Complaint 
  • Distributor – this definition is recognized by FDA, although the definition of “distributor” in Part 803 will remain unchanged. They are not identical; the QMSR definition is more expansive and includes retailers, because they make a device available to the end user. 
  • Implantable medical device – superseded by FD&C 
  • Importer 
  • Labelling – superseded by FD&C “Labeling” 
  • Life-cycle 
  • Manufacturer – superseded by FD&C “manufacturer” 
  • Medical device – superseded by FD&C “device” 
  • Medical device family 
  • Performance evaluation – related to the verification of an IVD 
  • Post-market surveillance 
  • Product   
  • Purchased product 
  • Risk 
  • Risk management 
  • Sterile barrier system 
  • Sterile medical device 

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