It has been a (very) long road. More than 7 years actually.
But yesterday, the FDA published its Quality Management System Regulation (QMSR) Final Rule that harmonizes its requirements with ISO 13485 with minimal additional requirements.
The FDA expects to ensure consistency in terms of regulatory expectations but also to save hundreds of millions of dollars annually.
Manufacturers were given a 2-year long transition period until 2 February 2026 to comply with the new rule (they will continue to use the current QS regulation until then).
Read the announcement here
Read the Rule here
Reach out to Evnia if you need help with your remediation and/or a gap analysis. Our team of FDA experts will guide you through!
