In February 2024, the FDA took a bold step that will change the regulatory landscape of the medical devices industry as we know it. The FDA published its final rule to align its Quality System Regulation (QSR) with the internationally recognized ISO 13485 standard, thereby creating a new regulation called the ‘Quality Management System Regulation (QMSR) Final Rule.’

In practice, this means that, from February 2026, U.S. device manufacturers must ensure their quality management systems now meet the more globally recognized requirements of ISO 13485.

To recognize the implications of this decision for businesses and consumers, we must first understand the medical device regulation landscape where a lack of continuity with global markets has impacted manufacturers operating in the U.S. and beyond.

The QSR Era

The birth of medical device regulation in the U.S. goes back to 1978, when the FDA issued a final rule requiring manufacturers to establish a quality system which became known as the Current Good Manufacturing Practice (CGMP). In the 1990s, a series of revisions to CGMP Regulation to include requirements for design controls and ensure compliance with other evolving quality system standards ultimately led to the publication of the Quality System Regulation (QSR) in 1996.

Since then, the QSR has been the bedrock of medical device regulation in the U.S., dictating the CGMP requirements that manufacturers must follow. The QSR is not a highly prescriptive set of rules, but a broad framework meant to enable manufacturers to develop processes and procedures tailored to their specific device and manufacturing technologies.

At its core, the QSR is inspection-driven. Without built-in parameters for risk management, the QSR instead ensures compliance through regular check-ins via a Correction and Preventative Action (CAPA) mechanism. These inspections are conducted by the FDA, as opposed to certified accreditation bodies, making it a highly centralized process.  

Another unique characteristic of the QSR is that it is specific to medical devices marketed in the U.S. As a result, medical device manufacturers, who often sell in multiple markets, must therefore navigate a complex regulatory landscape. Maintaining different quality systems to comply with various standards can be a costly and inefficient task – especially for smaller manufacturers.  

The Global Standard - ISO13485

The ISO13485 is the international gold standard for quality assurance in the medical devices industry. Unlike the QSR, it outlines the requirements for a comprehensive Quality Management System (QMS) across the entire lifecycle of medical devices, covering everything from design and development to production, installation, servicing, and disposal.

Unlike the inspection-heavy QSR framework, under ISO13485, safety and quality are guaranteed though a strong emphasis on risk management throughout the product lifecycle, an approach that is increasingly seen as critical to ensuring device safety and effectiveness. In the absence of a singular centralized regulatory body like the FDA, compliance is instead assured through accreditation by independent bodies such as BSI.    

Another key contrast from the QSR is that ISO13485 is intrinsically patient-centric. Emphasis on meeting customer requirements and enhancing customer satisfaction is embedded into the entire regulatory process.

ISO13485 certification therefore symbolizes not just basic compliance but a commitment to patient satisfaction, consistent quality and continuous improvement. As a result, it is not just a bonus but a mandatory prerequisite for marketing medical devices across many jurisdictions worldwide, including the EU, UK, Canada and Australia to name a few.

What’s Changing in 2026?

Under the final rule, the U.S. FDA has incorporated ISO 13485 “by reference,” a move that will transform the regulatory landscape of medical devices and, consequently, the global healthcare economy.

Incorporating ISO 13485 “by reference” means the FDA explicitly recognizes the standard’s robust framework for quality management systems as substantially equivalent to the existing QSR, acknowledging its widespread adoption and proven effectiveness in ensuring product safety and efficacy. This decision underscores a commitment to aligning with international best practices without impinging on the FDA’s rigorous oversight.

While the impact of this is significant, it’s crucial to dispel any misconceptions. The QMSR Final Rule does not mean that ISO 13485 certification will be required by the FDA, nor will manufacturers with ISO 13485 certification be exempt from FDA inspections. While the FDA will remain the principal regulatory authority, FDA inspections will not result in ISO 13485 certification, which will still require third party certification.

This begs the question – what does the incorporation of ISO 13485 “by reference” actually mean in practice? Rather than shifting QMS from the QSR to the ISO 13485 in its entirety, the final rule is instead an acknowledgement that a well-designed and implemented ISO 13485 system can provide a similar level of assurance in a manufacturer’s ability to consistently produce safe, effective, and compliant medical devices. The FDA understands that manufacturers following ISO 13485 already possess a strong foundation for meeting regulatory expectations.

The impact of this is significant. ISO 13485 recognition will help to reduce regulatory friction and improve market access internationally, the benefits of which will be felt across the entirety of medical device supply-chain, from designers and manufacturers right down to health practitioners and patients.

U.S. manufacturers will benefit from greater access to global markets, where not aligning to ISO 13485 has often been a barrier to entry. While the U.S. is already a major supplier of medical devices to Europe, closing the regulatory gap will reduce additional costs and burdensome administrative processes, making it easier for U.S. companies to enter the global market. For small and medium-sized businesses, the impact of this will be even more significant, as the reduced cost of international trade could make the difference between exporting globally or not, enabling them to compete more effectively on a global scale.

Equally, ISO 13485 compliant manufacturers are likely to experience a reduced compliance burden in the U.S., as they can leverage their existing QMS. In turn, this will enable more European manufacturers to penetrate the U.S. market, resulting in more choice for consumers making critical healthcare decisions. This influx of innovation and diverse product offerings benefit patients and providers alike.

Ultimately, the harmonization of global QMS in the medical devices industry will help to build a more sustainable healthcare economy. Healthy competition and reduced regulatory friction not only create more choice but also help to drive down prices and foster a culture of innovation and continuous improvement, leading to better outcomes for patients and a more robust healthcare system overall.

The Future of Medical Device Regulation

By embracing ISO 13485, the FDA is signaling its commitment to international harmonization, reducing the burden on manufacturers and fostering a more level playing field. In time, the impact of this change should be felt at the consumer level, where medical device users stand to benefit from greater choice, consistent quality, and a QMS that puts patient care as its number one priority.