The FDA Preamble - QMSR Final Rule

Publication of the US Food and Drug Administration’s (FDA) final rule amending the Current Good Manufacturing Practice (CGMP) requirement of the Quality System Regulation (QSR) (21 CFR Part 820), now being called the Quality Management System Regulation (QMSR), was the latest significant regulatory change that the US medical device has faced.

The final rule incorporates by reference (IBR) ISO 13485:2016 into the FDA regulation, expanding on a few provisions to ensure consistency with other applicable FDA regulations, including definitions and requirements. The new requirements become effective 2 February 2026.

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. There are only four areas where the requirements of ISO 13485:2016 and QMSR (new Part 820) are not substantively similar, as indicated in the following table:

There is, however, another part of the Final Rule that plays a critical role in the application of the QMSR and provides additional supportive information. That part is called the Preamble.

What is the Preamble?

A preamble is defined by The Oxford Dictionary as ‘a preliminary or preparatory statement; an introduction.’

When the CFR was established in 1938, it was accompanied by the Preamble, which serves as an introduction to, and explanation of, the regulations being issued. It provides background information, rationale behind the regulations, and often outlines the public comments received during the rulemaking process and how the agency addressed them. The Preamble is important for understanding the intent and context of the regulations and helps stakeholders interpret and comply with the requirements.

A preamble is published along with the final regulation in the Federal Register, and contains the following elements:

1. The name of the agency, 
2. the nature of the action e.g., final rule, notice, 
3. a summary first paragraph describing the substance of the document in easily understandable terms, 
4. relevant dates, e.g., the rule's effective date and comment closing date, if an opportunity for comment is provided, 
5. the name, business address, and phone number of an agency contact person who can provide further information to the public about the notice, 
6. an address for the submission of written comments when they are permitted, 
7. supplementary information about the regulation in the body of the preamble that contains references to prior notices relating to the same matter and a summary of each type of comment submitted on the proposal and the Commissioner's conclusions with respect to each,
8. a thorough and comprehensible explanation of the reasons for the Commissioner's decision on each issue. [1]

View here

Does the Preamble change?

There are several reasons for when an update is made to a preamble, the most common ones being when changes are made to regulations, and when the Agency receives comments and feedback.

Regulations may be updated in response to new laws, court rulings, emerging issues, or new technologies. If there are amendments, revisions, or new regulations issued by the Agency, the Preamble may be updated accordingly to reflect these changes.

Before a regulation is being finalised, the Agency may solicit public comments and feedback on the proposed rule, as was done with the proposed (now final) change to the QSR. Public comments may lead to revisions or clarifications in the final rule, as well as in the preamble. Depending on the volume and complexity of the comments received, updating the preamble may take some time.

Regulations may also go under periodic review and evaluation to ensure they are still effective, relevant, and in line with current needs and priorities. As part of this process, the Agency may update the preamble to reflect any changes or updates to the regulation.

Is the Preamble important?

While not technically a part of the regulation, the preamble contains important information on, and gives context to, the development of the regulation.

From an historical context, the preamble provides insights into the historical development of the regulation. As it includes information about the events, concerns, or incidents that led to the creation or revision of the regulation, understanding the context can help stakeholders appreciate the rationale behind the requirements.

Another benefit to the preamble is that it summarizes the public comments received during the rulemaking process. This provides insight into various perspectives, concerns, and suggestions from industry stakeholders, consumer groups, healthcare professionals, and other interested parties. It also demonstrates the FDA's consideration of public input in shaping the final rule.

Stakeholders can further benefit from reading the preamble as it often includes information on the challenges or concerns related to implementing the regulation. This could include issues such as compliance difficulties, resource constraints, or technological limitations. Acknowledging these challenges can help stakeholders anticipate and address potential hurdles in complying with the regulation.

Lastly, the preamble may also provide clarification to the FDA's enforcement policies regarding the regulation. This could include information on inspection procedures, enforcement discretion, or the agency's approach to non-compliance. Understanding the FDA's enforcement priorities and strategies can help stakeholders prioritize their compliance efforts and mitigate risks.

Conclusion (or, dare I say, Postamble)

Overall, while the Preamble to 21 CFR Part 820 may not always be considered the most riveting read, it does contain valuable information that can help stakeholders understand the regulatory landscape governing medical devices in the United States. Therefore, it is important to read the Preamble in addition to the regulation to better understand the context, comments, and decisions leading to the Final Rule.

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

This blog is a follow to the previously published blogs this year titled ‘FDA and ISO 13485 – Cause for Concern or Celebration?’ and ‘The New FDA 21 CFR Part 820 – Quality Management System Regulation’

Part 1: FDA and ISO 13485 – Cause for Concern or Celebration?

Part 2: The New FDA 21 CFR Part 820 – Quality Management System Regulation