The Quality Management System Regulation (QMSR) is FDA's current medical-device quality-system regulation in 21 CFR Part 820. It became effective February 2, 2026 and incorporates by reference ISO 13485:2016, along with certain FDA-specific requirements and definitions.

QMSR became effective on February 2, 2026. FDA also stopped using the former Quality System Inspection Technique (QSIT) on that date and began using the inspection process described in Compliance Program 7382.850.

QMSR applies to finished device manufacturers that intend to commercially distribute medical devices. FDA defines a finished device to include devices and certain accessories that are suitable for use or capable of functioning. Device-specific CGMP exemptions may apply, so the exact obligation should be confirmed for the product and activity.

Yes. FDA classification regulations identify certain devices that are exempt from some current good manufacturing practice requirements. An exemption does not necessarily remove every quality-system obligation; for example, FDA notes that complaint-file and certain record requirements can still apply.

No. ISO 13485:2016 is the foundational quality-management standard incorporated into QMSR, but FDA-specific requirements under the FD&C Act and implementing regulations still apply. A third-party ISO 13485 certificate is not an FDA certification and does not by itself establish FDA compliance.

FDA requires compliance with QMSR, which incorporates ISO 13485:2016 by reference. FDA does not require manufacturers to obtain a third-party ISO 13485 certificate merely to satisfy QMSR. Certification may be commercially useful or required in other markets, but it is separate from FDA's regulatory determination.

A gap assessment typically compares the manufacturer's current quality-management system, procedures, records, and implementation against applicable QMSR and ISO 13485:2016 requirements. The output should identify gaps, risk priorities, responsible owners, and a practical remediation plan.

Yes. Support can include quality manuals, procedures, work instructions, document and record controls, supplier controls, complaint processes, CAPA, management review, internal audit processes, training records, and other documentation that applies to the manufacturer's operations.

QMSR incorporates ISO 13485:2016, which uses a risk-based approach throughout the quality management system. Manufacturers should integrate risk-based decision-making into applicable design, production, supplier, process, and postmarket activities rather than treating risk management as a one-time document.

FDA discontinued QSIT on February 2, 2026. Device inspections now use the process described in the updated Inspection of Medical Device Manufacturers Compliance Program 7382.850, which aligns the inspection program with QMSR.

Yes. FDA's QMSR FAQ states that the prior record-review exceptions for management review, quality audits, and supplier audit reports were not retained. FDA may review those records during inspection, so they should be maintained and inspection-ready.

QMSR applies to covered finished device manufacturers marketing devices in the United States regardless of whether the facility is domestic or foreign. FDA may inspect foreign manufacturing facilities, and the same device-specific exemptions and activity-based analysis should be considered.

No. QMSR is the quality-system framework. Establishment registration and device listing, labeling and UDI, Medical Device Reporting, corrections and removals, and other FDA requirements remain separate obligations when applicable.

Quality-system deficiencies can lead to FDA observations and enforcement action, and significant compliance problems may affect certain regulatory decisions. The consequence depends on the device, submission type, findings, and corrective actions, so the page does not promise that any single QMS issue automatically causes a specific enforcement outcome.

QMSR does not create one universal annual external-review requirement for every manufacturer. The manufacturer should operate the quality system continuously and perform required management-review, audit, training, CAPA, and other activities at appropriate planned intervals based on its procedures, risks, and applicable requirements.

Send us your facility details, device types, current quality-system status, existing ISO 13485 certification if any, and the areas you want assessed. We can scope the engagement for gap assessment, documentation support, remediation planning, mock inspection, or ongoing quality-system support.