The New FDA 21 CFR Part 820 – Quality Management System Regulation

It has now been two months since the US Food and Drug Administration (FDA) published its final rule amending the Current Good Manufacturing Practice (CGMP) requirement of the Quality System Regulation (QSR) (21 CFR Part 820) to incorporate by reference, and thereby align more closely with, the international consensus standard ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes. 

The new regulation, referred to as the Quality Management System Regulation, or QMSR for short, is the medical device industry’s latest significant regulatory change and move towards more consistency in the global regulatory framework.

With the publication of the final rule, the FDA have provided additional clarification and information so manufacturers may start to plan implementation strategies ahead of the effective date of 2 February 2026.

Overview of QMSR (the new part 820)

The final rule makes three significant changes to the FDA regulation. The first being that it withdraws most of the requirements found in the previous part 820. It does, however, retain the scope and some definitions from the QSR.

In addition, it incorporates by reference (IBR) ISO 13485:2016, calling out a few provisions to ensure consistency with other applicable FDA regulations, including definitions and requirements. Also included in the IBR is clause 3 of ISO 9000:2015, Quality management systems-- Fundamentals and vocabulary, which contains terms and definitions necessary for the application of ISO 13485. It is important to note that incorporation by reference is not the same as recognizing the standard for use on a Declaration of Conformity, as IBR makes using the standard a legal requirement rather than a voluntary option.

Lastly, the new QMSR includes conforming edits to the current Good Manufacturing Practice (cGMP) regulation for combination products (21 CFR Part 4) to clarify the medical device requirements and to align with ISO 13485 and the final rule. However, these edits do not impact the GMP requirements for combination products.

Changes to Terms and Definitions

The definitions in Clause 3 of ISO 13485:2016 and ISO 9000:2015 now apply to the QMSR, except for those terms specified in §820.3(b) [1] or provided as statutory definitions in section 201(h) of the FD&C Act (21 USC 321) (e.g., device, labeling) that have definitions not included in or superseding those in the standards. These terms include:

• implantable medical device [2]
• manufacturer  [3]
• organization  [4]
• rework [5]
• safety and performance [6]

The QMSR §820.3(a) also includes five additional terms that are not defined in either ISO 13485:2016 or ISO 9000:2015. 

• Component [7] - any raw material, substance, piece, part, software, firmware, labeling, or assembly that is intended to be included as part of the finished, packaged, and labeled device.
• FD&C Act [8] - Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321  et seq., as amended.
• Finished device [10] - any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
• Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device [11] - an HCT/P as defined in § 1271.3(d) that does not meet the criteria in § 1271.10(a) and that is also regulated as a device.
• Remanufacturer [12] - any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.

Similarities and Differences between QSR and ISO 13485:2016

The FDA has been a strong participant in the development of ISO 13485, so it is not surprising that the requirements between the QSR (current Part 820) and ISO 13485:2016 are substantively similar, with key differences in just four areas:

In addition to meeting the requirements in ISO 13485:2016, Clause 4.2.5, manufacturers must also meet the additional requirements in Section §820.35, Control of Records:

• Information required by 21 CFR Part 803 related to complaint and servicing activities;
• Documentation required to meet Unique Device Identification (UDI) requirements of 21 CFR Part 830;
• Confidentiality of records sent to and received by the FDA.

The FDA has retained requirements from the QSR in Section §820.45, Control of Device Labeling and Packaging, intended to strengthen controls for labeling and packaging operations as they feel ISO 13485:2016 fails to provide additional requirements addressing labeling inspection activities. Manufacturers must meet these requirements as well as those in ISO 13485:2016, Clause 7.5.1(e).

Structure of the QMSR

The structure of the QMSR will change to support the IBR of ISO 13485:2016 and remove those subparts that the FDA has determined to be substantively similar. The subparts that are substantively similar are identified as ‘reserved’.

Section §820.10, Requirements for a quality management system, links in the additional applicable FDA requirements for medical device reporting, unique device identification, corrections and removal, tracking, and the applicability of design and development activities

Figure 1: Current Part 820 Quality System Regulation vs NEW Part 820 Quality Management System Regulation

Final Thoughts

As the new QMSR goes into effect 2 February 2026, manufacturers must continue to comply with the current QSR, while planning an implementation strategy to the QMSR. After this date, the FDA will continue to retain its inspectional authority, although there will be revisions to policies, procedures, and inspection processes.

The FDA will not require ISO 13485 certification and manufacturers with a certificate are not exempt from FDA inspections. Additionally, inspections will not result in issuance of certificates of conformance (CoC) to ISO 13485:2016, although manufacturers may choose to become certified if selling or planning to sell into other jurisdictions.

[1] https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments#p-430.

[2] https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments#p-431.

[3] https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments#p-432.

[4] https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments#p-433.

[5] https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments#p-434.

[6] https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments#p-435.

[7] https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments#p-425.

[8] https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments#p-426.

[9] https://www.govinfo.gov/content/pkg/USCODE-2022-title21/pdf/USCODE-2022-title21-chap9-subchapII-sec321.pdf.

[10] https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments#p-427.

[11] https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments#p-428.

[12] https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments#p-429.

This blog is a follow on to my blog published last month titled ‘FDA and ISO 13485 – Cause for Concern or Celebration?’