Easier QMS compliance in Canada and the US

It’s now official! The FDA ruling on its 21 CFR 820 earlier this year has made for easier QMS compliance in Canada and the US.  For a few years now the FDA has been taking steps to align its Quality System Regulations.  More specifically, it has been working towards alignment with ISO 13485.  As of January 31, 2024, the FDA officially revised its 21 CFR 820 to align with ISO 13485.  Well, certain “expectations and concepts” of it, at least.  Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions | FDA

Always been very similar

The FDA has accepted market submissions with ISO 13485 certified QMS’s for some years now.  However, it also required compliance to its 21 CFR 820 Quality System Regulations.  The two have been very similar, with subtle differences (there are lots of articles online that cover this topic).  Despite this, medical device manufacturers have had to maintain clear dual-compliance in their QMS.  The two are different, as well.  ISO 13485 is an International Standard.  Many countries require it for market approval.  The FDA’s 21 CFR 820 is an enforced law to gain market entry to the United States.

Quality Managers have always had to keep a keen eye on both requirements, and manage a cross-referenced QMS.  This new alignment means that it’s even easier to meet 21 CFR 820 requirements than ever before.  The door is open for easier QMS compliance in Canada and the US.  There’s that collective sigh of relief from Quality managers.  Hear it?

Globally aligned regulations

It’s “still business as usual” by means of certification audits, though. This final rule doesn’t change how your QMS is certified.  FDA inspections still wont certify your QMS to ISO 13485.  Before you ask, the FDA has no plans to develop an ISO 13485 certification program, either.  It also means you must still undergo FDA inspections for US market registrations.  Nothing has changed there.

However, it means that a 13485 QMS is now more easily managed for compliance to the FDA requirements.

21 CFR 820 is now known as the QMSR, or Quality Management System Regulations.  This rebranded law amends the device current good manufacturing practice (CGMP) requirements of the former Quality System (QS) Regulation under 21 CFR 820 to align more closely with those of ISO 13485:2016.  How closely?

The FDA has stated that the new QMSR “incorporates by reference” the QMS requirements of ISO 13485.  The agency has determined that these requirements are “substantially similar” to the former 21 CFR 820 QSR.  In any case, the FDA felt that both sets of requirements allow an organization to effectively demonstrate the development of safe and effective medical devices.

This change also better aligns the United States with other global agencies.  Perhaps this makes the US more appealing to international device manufacturers?

Driven by the audit model

Harmonization programs like MDSAP (Medical Device Single Audit Program) certify against the ISO 13485 requirements and those of the additional country-specific requirements.  The FDA found that very few of the 21 CFR 820 requirements needed to be added to the MDSAP process. ISO 13485 already covered these requirements.

the MDSAP process is required by organizations looking to enter both the Canadian and US markets, anyhow.  This new ruling means they will now more easily comply with the harmonized QMS requirements.

Impact and timeline

Getting to market may be a bit simpler than ever before with the removal of duplicative requirements because even the review process is now more harmonized.  The FDA has the confidence in the ISO 13485 requirements and no longer needs to perform additional verification of them to more than one regulation.

Here is a summary of what important elements of ISO 13485:2016 the FDA has referenced into the new QMSR:

• Risk Management processes in product realization
• Align closer to the continuous improvement requirements by referencing the data analysis and complaint handling processes
• Redefining the rework requirements
• Align with Safety and Performance requirements
• Replace many terms of the same meaning with those from ISO 13485
• Record approval and document management requirements

Now, all of this doesn’t mean that you have to scramble to make changes right away.  We have the time required to work together to enhance your QMS.  The new QMSR requirements will be enforced upon the effective date, February 2, 2026.  

This gives ample time for anyone operating on an existing 21 CFR 820 QMS to upgrade it to the new QMSR and be ready for FDA inspections.  In fact, there has never been a better time to approve the business case to implement an ISO 13485 QMS!

It also makes things easier for those using or looking to operate under a certified ISO 13485 QMS because the compliant output is now more harmonized and recognized by the FDA.

Providing a clearer pathway to an optimized Quality Management System

The take away from this is that the FDA has made its QMS requirements more aligned with ISO 13485, thus allowing for a more unified medical device development process and a simpler audit and certification process of your QMS.  To get to market you will need a QMS  anyhow.  It makes sense to certify your QMS to ISO 13485 now more than ever!

If you would like to learn more about how an ISO 13485 QMS with the new FDA QMSR built-in can work for you and your product development strategy, or are looking to learn more about upgrading your current QMS, contact Paul Needler, Managing Director and QMS Specialist at NeedlerQMS.

 

 

 

Knowing the changing landscape of the regulations means staying on top of effective Quality Management System management. Changes made by regulators can make it easier and requires analysis and planning to effectively support the strategy for your business.

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