Overview of the FDA's new Quality Management System Regulation: effective from 2 February 2026

We already have reported more often on the FDA's CDRH Learn website. Now there are new modules available, specifically on the new Quality Management System Regulations that will come into effect for medical devices in the USA on 2 February 2026. What do the slides show?

Under the title 'Navigating the Quality Management System Regulation (QMSR)', Tonya A. Wilbon from CDRH provides an overview of these regulations in 31 slides. The learning objectives are:

• Purpose and scope of the QMSR
• Overview of key requirements of the QMSR (with references to ISO 13485:2016 and ISO 9000:2015)
• Comparison of the 'Part 820' regulations of 1996 and 2024
• Ways to achieve regulatory changes

Right at the outset, it is pointed out that there are definitions in 21 CFR 820 that go beyond ISO 13485 and ISO 9000. Much of this is resolved by an insertion in 21 CFR 820 with references to ISO 13485 (incorporation by reference, IBR). Parts 820.1, 820.3, 820.10, 820.35 and 820.45, among others, are mentioned with reference to ISO 13485. Article 820.10 on the requirements for a QM system also explicitly refers to other applicable requirements. The following parts are mentioned:

• 21 CFR 830 "UDI"
• 21 CFR 821 "Medical Device Tracking Requirements" 
• 21 CFR 803 "Medical Device Reporting"
• 21 CFR 806 "Medical Devices; Reports of Corrections and Removals "

But how should the new regulations be implemented? The FDA recommends four steps.

1.) Familiarise yourself with the regulations.
2.) Conduct a 'GAP' analysis to identify gaps and incorporate the new requirements into these gaps.
3.) Implement robust documentation.
4.) Promote a culture of compliance (including training and monitoring of the newly introduced elements).

The core of the presentation is a tabular comparison between the 1996 regulations and the current 2024 regulations. Almost all sections refer to insertions (IBR), so the tables are relatively concise. 

In another set of slides (36 slides) entitled 'Quality Management System Regulation - Risk Management, Risk-Based Approach, and Risk-Based Decisions', Tonya A. Wilbon describes risk elements in a QMSR. The main part of the presentation shows the elements of ISO 13485 that deal primarily with the topic of risk management. Of particular interest are examples of risk documentation, such as risk management plans and files.

Conclusion: The two modules on QMSR are manageably comprehensive and provide a quick, compact insight into the topic. If desired, you can also listen to the lectures if you would like more information on the slides.

You can find the two modules on the CDRH Learn page.