FDA Transitions to QMSR: Immediate Actions for Manufacturers

Effective Monday, February 2, 2026, the FDA officially transitioned to the Quality Management System Regulation (QMSR). No longer will the FDA recognize the former Quality System Regulation, and manufacturers may be subject to FDA compliance actions if the transition has not been completed. 

This change means that your quality management system must now reference and follow the requirements of ISO 13485:2016, in addition to the revised FDA requirements, including those published in: 

• 21 CFR Part 820.10 – Requirements for a Quality Management System 

• 21 CFR Part 820.35 – Control of Records 

• 21 CFR Part 820.45 – Device Labeling and Packaging Controls 

It is important to note that FDA has clarified that manufacturers are not required to be certified to ISO 13485:2016 by an Auditing Organization; however, compliance to the standard is the expectation.

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What Manufacturers Should Do Now 

If you have not yet initiated this transition, the time to act is now. 

Manufacturers should begin with a gap assessment of their existing quality management system against the requirements of ISO 13485:2016 and the FDA’s recently published Quality Management System Regulation (QMSR). 

Key Steps Include: 

• Reviewing all quality system procedures (SOPs) for references to the now-superseded 21 CFR Part 820 

• Updating references accordingly to 21 CFR 820 Quality Management System Regulation 

• Confirming that procedures align with the revised regulatory structure 

For example, procedures for managing customer complaints should no longer reference 21 CFR 820.198, but instead reference 21 CFR 820.35(a) and ISO 13485:2016 §8.2.2. 

Training and Inspection Considerations:

All quality system procedures (SOPs) should be reviewed and updated as needed. Importantly, training should not be limited to the Quality team. All relevant staff should be trained on: 

• The transition to the Quality Management System Regulation 

• Any updates made to quality system procedures 

Manufacturers should also be aware that under the QMSR, the FDA will now have access to: 

• Internal audit records 

• Supplier audit records 

• Management review records 

With the release of the new QMSR it was necessary for FDA to update their inspection program.  Previously FDA followed an inspection process known as the “Quality System Inspection Technique” (QSIT), however, with the QMSR FDA has issued a new Compliance Program Manual “Inspection of Medical Device Manufacturers” (Inspection of Medical Manufacturers – 7382.850), FDA will be increasing their focus on Risk Management and control over outsourced processes and contract manufacturers. If you are preparing for an FDA inspection, it is important that you review FDA new Compliance Program Manual.

How MedEnvoy Can Support with FDA Transitioning to the QMSR

Compliance with the FDA’s QMSR is now in effect. 

If you are looking for assistance with transitioning your quality management system to the QMSR, MedEnvoy Global can support you by: 

• Conducting the required gap assessment 

• Supporting updates to quality system documentation 

• Assisting with staff training on QMSR requirements 

If you have any questions regarding this summary or the accompanying guidance document, we encourage you to contact our team for tailored support.