FDA Aligns Device Rules With Global Standard

  New QMSR aligns US device rules with ISO 13485 and tightens oversight for combination products and their suppliers  

12 Feb 2026

A quiet regulatory shift is sending a loud message to drug and device makers: tighten up.

In February 2026, the US Food and Drug Administration’s Quality Management System Regulation took effect, formally aligning 21 CFR Part 820 with ISO 13485:2016. The move updates longstanding medical device quality system rules and brings them closer to global standards.

On paper, the FDA has framed the change as harmonization, not upheaval. Statutory current good manufacturing practice requirements for combination products remain intact. But in practice, companies are being asked to rethink how their quality systems operate, integrate, and stand up to scrutiny.

For manufacturers of long acting injectables, prefilled syringes, and wearable delivery systems, the implications are immediate. Drug and device processes must now mesh seamlessly. Risk management frameworks need to be clearly documented and consistently applied. Corrective and preventive action systems must show they work, not just exist on paper.

Inspection dynamics are also evolving. The FDA has indicated that investigators will assess compliance through the lens of the revised framework, with particular attention to supplier controls and risk based decision making. That means sponsors cannot treat contract manufacturers or component suppliers as distant partners. Oversight must be active, structured, and well documented.

The ripple effects extend across supply chains. Companies operating under 21 CFR Parts 210 and 211, along with Part 4 for combination products, are expected to demonstrate that responsibilities are clearly defined and quality data flows across organizational lines.

There is an upside. Greater alignment with ISO 13485 may ease global expansion by reducing the need for parallel quality systems in US and international markets. For firms planning multi region launches, audit preparation could become more streamlined.

Still, modernization comes at a cost. Smaller biotech firms and emerging device developers may face new spending on training, procedural updates, and system upgrades. The rule may not be a wholesale rewrite, but it undeniably raises expectations.

As combination products gain ground in oncology, immunology, and beyond, the companies that treat QMSR as a strategic opportunity rather than a compliance chore will be best positioned for what comes next.