Frequently Asked Questions about the FDA QMSR

Although the FDA has done an excellent job of laying out QMSR requirements and explaining differences between the QSR and the QMSR, there are questions related to the implementation of the new Quality Management System Regulation (QMSR) that need an answer.

This page contains FAQs for your review, and we will be adding more, so you may want to bookmark this page.

And if you have a question about the requirements or methods involved in making a Quality System changeover, please let us know.

QMSR FAQs

General Questions about the QMSR

Q: What is the FDA QMSR?
A: The FDA Quality Management System Regulation (QMSR) is the updated regulatory framework that replaces the Quality System Regulation (QSR) for medical device manufacturers. It aligns with ISO 13485:2016 to harmonize FDA requirements with global quality management standards.

Q: Why was the QSR updated to QMSR?
A: The update to QMSR aims to streamline compliance, reduce regulatory burdens for companies operating globally, and ensure that medical devices meet consistent worldwide quality and safety standards .

Implementation and Compliance

Q: When does the QMSR go into effect?
A: The QMSR transition period is expected to be [insert relevant timeline based on the latest FDA announcements], giving manufacturers time to adapt their quality systems.

Q: How do I know if my company complies with the QMSR?
A: Companies can assess compliance by performing a gap analysis between their existing quality systems under QSR and the requirements of ISO 13485:2016 as outlined in the QMSR.

Q: What are the key differences between the QSR and QMSR?
A: The QMSR incorporates the structure and requirements of ISO 13485:2016, including risk-based approaches, supplier controls, and updated documentation practices. While many core principles of QSR remain, the QMSR emphasizes alignment with international standards.

Q: Will our company be required to have a quality manual?
A: Yes. Although the current QSR does not require a quality manual, the new connections with ISO 13485 mean that you must have a quality manual.

Q: Must our quality system be certified to ISO 13485?
A: No. The QMSR (21 CFR 820) has more (and some different) requirements than those documented in ISO 13485. ISO certification certificates will not be accepted to show compliance, and your quality system should comply with the QMSR as well as ISO 13485.

Q: Can I implement a QMSR-compliant quality system now, instead of waiting for 2 February 2025?
A: Your quality system must be compliant with the current QSR through 1 February, 2026. That said, there are some updates that can be accomplished in the interim, which underscores the need to have a comprehensive quality system update strategy and plan.

For Current and New Manufacturers

Q: Do I need to implement a new quality management system?
A: If your current system is based on ISO 13485:2016, adjustments may be less than if your quality system is based on the FDA QSR. If your system is strictly QSR-compliant, you will need to modify it to align with the QMSR requirements, including those listed in ISO 13485.

Q: What happens if we don’t comply with the QMSR by the deadline?
A: Noncompliance can lead to FDA enforcement actions, including warning letters, product recalls, import alerts, or fines. It is critical to ensure your quality management system is compliant before the deadline.

Technical and Training Support

Q: What resources are available to help with the transition to the QMSR?
A: Resources include FDA guidance documents, training programs, and consulting services from firms like Medical Devices and Pharma (MDP) that specialize in regulatory transitions and quality systems.

Q: Do employees need additional training for QMSR compliance?
A: Yes, employees involved in quality management and compliance should be trained on QMSR requirements, particularly if transitioning from a QSR-only framework.

Specific Topics

Q: How does the QMSR handle supplier controls?
A: QMSR aligns with ISO 13485:2016, requiring robust supplier qualification processes, performance monitoring, and risk management to ensure the quality of purchased materials and services.

Q: Are design controls different under the QMSR?
A: The design control principles under QMSR remain similar to QSR but are aligned with ISO 13485:2016 standards, emphasizing risk management and traceability.

Q: Will the QMSR apply to combination products?
A: Yes, QMSR applies to combination products, and 21 CFR Part 4 will also be implemented on 2 February 2026. See the FDA Final Rule released in February 2024 for more details.

Getting Help

Q: Where can I find the full text of the QMSR?
A: The full text of the QMSR Final Rule can be found in the Federal Register or on the FDA website. 

Q: How can MDP help my company transition to QMSR compliance?
A: Medical Devices and Pharma (MDP) offers gap analysis, quality system updates, employee training, and ongoing consulting to ensure a smooth and effective transition to QMSR compliance.