By Jordan Smith, March 10, 2026
ANKOM Technology
Effective February 2, 2026, the FDA has officially transitioned to the Quality Management System Regulation (QMSR), marking a significant shift in compliance expectations for manufacturers. The former Quality System Regulation has been rendered obsolete, meaning that all manufacturers must take immediate steps to align their quality management systems with this new directive to avoid potential compliance actions from the FDA.
Understanding the Shift to QMSR
This transition requires that your quality management system (QMS) not only adheres to the revised FDA requirements but also references the international standard ISO 13485:2016. Relevant regulations to note include:
- 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
While the FDA has clarified that manufacturers are not mandated to obtain certification from an auditing organization specifically for the ISO standard, compliance with its principles remains an essential expectation for all involved parties.
Action Steps for Manufacturers
If your organization has not yet initiated a transition to the QMSR, it is critical to act promptly. Manufacturers should commence with a thorough gap assessment of their current quality management systems in comparison to the updated requirements outlined in ISO 13485:2016 and the new QMSR.
Key Steps Include:
- Reviewing all quality system procedures (Standard Operating Procedures or SOPs) for any references to the now-outdated 21 CFR Part 820,
- Updating all references to reflect 21 CFR 820 Quality Management System Regulation,
- Ensuring that all procedures are in alignment with the new regulatory framework.
As an example, procedures for managing customer complaints should reference 21 CFR 820.35(a) and ISO 13485:2016 §8.2.2 rather than the previously applicable 21 CFR 820.198.
Training and Compliance Preparation
Every SOP must be reviewed and updated to ensure complete compliance. Furthermore, training should extend beyond the quality assurance team; all pertinent staff should receive training on:
- The transition to the Quality Management System Regulation,
- Any updates to quality system procedures.
Under the QMSR, it is vital to recognize that the FDA will have increased access to key documentation, including:
- Internal audit records,
- Supplier audit records,
- Management review records.
Moreover, with the introduction of the QMSR, the FDA has revamped its inspection protocol. Previously, the FDA utilized the Quality System Inspection Technique (QSIT), but under the new compliance framework, it has established the “Inspection of Medical Device Manufacturers” manual, now emphasizing risk management and oversight of outsourced processes and contract manufacturers. Manufacturers preparing for FDA inspections are strongly encouraged to consult this new compliance program manual for guidance.
How to Navigate the QMSR Transition
Compliance with the FDA’s QMSR is non-negotiable and now in effect. For organizations seeking assistance with this transition, consulting experts can yield significant benefits. Support services may include:
- Conducting the required gap assessment,
- Facilitating updates to quality system documentation,
- Assisting with comprehensive staff training on QMSR requirements.
Should you have any queries regarding this transition or require tailored support, do not hesitate to contact us.
Related Guidance and Best Practices
It is essential to support manufacturers during this transition by sharing insights and resources that promote effective practices and compliance. Continuous education, adherence to updated regulations, and active engagement with the latest compliance directives are critical in ensuring seamless operations within the regulatory landscape.
Moving forward, manufacturers in sectors such as medical device production must stay informed about legislative changes and trends within the healthcare landscape to maintain compliance and deliver quality products to market.
Disclaimer: This article is for informational purposes only and does not constitute legal or professional advice. For specific guidance tailored to your organization, please consult a compliance professional or legal advisor.