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Medical device quality team reviewing FDA QMSR requirements
By: KendallPC
September 4, 2026

FDA’s Quality Management System Regulation is Now in Effect: What U.S. Medical Device Companies Need to Know.

The U.S. Food and Drug Administration’s (“FDA”) Quality Management System Regulation (“QMSR”) became effective on February 2, 2026, significantly updating the quality-system framework applicable to medical device manufacturers under 21 C.F.R. Part 820.

For medical device companies, the change is more than a terminology update. The QMSR incorporates ISO 13485:2016 by reference and establishes it as the foundational quality-management-system framework for covered medical device manufacturers, while retaining FDA-specific requirements under the Federal Food, Drug, and Cosmetic Act and FDA regulations.

Who Is Subject to the QMSR?

The QMSR generally applies to manufacturers of finished medical devices intended for commercial distribution in the United States. FDA defines a finished device broadly to include a device or accessory that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Certain devices are exempt from some current good manufacturing practice requirements under FDA classification regulations. Accordingly, companies should evaluate the classification and regulatory status of their particular device rather than assume that every device is subject to identical requirements.

Does a Medical Device Company Need a Quality Management System?

For manufacturers subject to the QMSR, yes. FDA states that manufacturers must establish and follow the QMSR to help ensure that their products consistently meet applicable requirements and specifications.

This is particularly important for early-stage companies. A quality management system should not be viewed simply as a binder of standard operating procedures created immediately before an FDA inspection. The QMS should be integrated into the company’s development, design, manufacturing, supplier-management, complaint-handling, corrective-action, and other applicable quality processes.

QMSR and ISO 13485:2016

One of the most significant changes is FDA’s incorporation by reference of ISO 13485:2016, the international quality-management-system standard for medical devices. FDA’s objective is to more closely align the U.S. framework with quality-system requirements used by other regulatory authorities.

Importantly, incorporation of ISO 13485 does not mean that FDA has simply replaced U.S. law with an international standard. Where ISO 13485 conflicts with the FD&C Act or FDA’s implementing regulations, U.S. statutory and regulatory requirements control.

Does FDA Require ISO 13485 Certification?

Medical device companies should distinguish between complying with the QMSR, which incorporates ISO 13485:2016, and obtaining an ISO 13485 certification from a third-party certification body. FDA’s QMSR establishes regulatory requirements; it does not, by itself, make third-party ISO certification the same thing as FDA compliance.

A company’s regulatory strategy should therefore consider both its U.S. FDA obligations and any separate certification or international-market requirements applicable to its business.

FDA Has Also Changed How It Inspects Medical Device Manufacturers

The QMSR became effective alongside a major change to FDA’s inspection process. On February 2, 2026, FDA discontinued the Quality System Inspection Technique (“QSIT”) and began using the inspection process described in Compliance Program 7382.850.

Companies preparing for an FDA inspection should therefore evaluate their readiness against the current QMSR framework rather than relying on an inspection-readiness program built solely around the former QS Regulation and QSIT.

FDA Can Now Review Records That Previously Received Special Treatment

Another important change concerns records available to FDA investigators. FDA’s QMSR Frequently Asked Questions explain that investigators may review management-review reports, quality-audit reports, and supplier-audit reports. The prior exceptions for these records under former 21 C.F.R. § 820.180(c) were not retained in the QMSR.

That change makes the quality and consistency of internal QMS documentation even more consequential. Medical device companies should consider not only whether required processes occur, but whether the resulting documentation accurately and appropriately reflects those processes.

What About Companies That Outsource Manufacturing?

Outsourcing manufacturing does not necessarily eliminate a medical device company’s FDA quality-system responsibility. Depending on the company’s role and activities, supplier qualification, purchasing controls, quality agreements, change controls, complaint handling, and oversight of contract manufacturers may remain important components of the company’s compliance structure.

Device companies using contract manufacturers should clearly identify which entity performs each quality function and ensure that responsibilities are appropriately documented and implemented.

When Should a Start-Up Build Its QMS?

The appropriate timing depends on the device, development stage, regulatory pathway, and company activities. As a practical matter, companies should evaluate QMS requirements early enough that required design, risk-management, supplier, verification, validation, and other quality records are created contemporaneously rather than reconstructed shortly before commercialization or an FDA submission.

For companies pursuing a 510(k), De Novo request, or PMA, quality-system planning should be coordinated with the overall regulatory and product-development strategy.

What Medical Device Companies Should Do Now

  • Determine whether the company and its products are subject to the QMSR and whether any exemptions apply.
  • Assess the existing QMS against the revised 21 C.F.R. Part 820 and incorporated ISO 13485:2016 requirements.
  • Identify gaps in design and development, risk management, supplier controls, complaint handling, CAPA, document controls, and other applicable quality processes.
  • Review quality agreements and responsibilities with contract manufacturers and critical suppliers.
  • Evaluate internal audit, supplier audit, and management-review documentation in light of FDA’s expanded inspection access.
  • Update FDA inspection-readiness procedures to reflect the new QMSR-aligned inspection process.
  • Coordinate QMS implementation with the company’s 510(k), De Novo, PMA, and commercialization strategy.

How Kendall PC Can Help

Kendall PC advises medical device manufacturers, start-ups, and life sciences companies on FDA regulatory strategy, quality-system compliance, and commercialization. We work with companies to identify regulatory requirements early and develop practical compliance strategies appropriate for the company’s products, development stage, and business model.

  • QMSR applicability and gap assessments;
  • FDA quality-system and inspection-readiness strategy;
  • 510(k), De Novo, and other medical device regulatory pathway assessments;
  • quality and regulatory SOP review;
  • contract-manufacturer and supplier quality arrangements;
  • medical device labeling and promotional review;
  • FDA compliance assessments; and
  • pre-market and commercialization regulatory strategy.

For companies developing, manufacturing, or preparing to commercialize a medical device in the United States, addressing QMS requirements early can reduce regulatory risk and help avoid costly remediation later in the development or commercialization process.

FDA Resources

This article is provided for informational purposes only and does not constitute legal advice. The application of FDA requirements depends on the particular device, manufacturer, activities, and circumstances.