How To Get Ready For 21 CFR Part 820/ISO 13485 Harmonization

In 1997, the U.S. Food and Drug Administration (FDA) introduced the Quality System Regulation (QSR), 21 CFR Part 820, which set the framework for quality management systems in medical device manufacturing. Around the same time, the International Organization for Standardization (ISO) issued ISO 13485, a global standard for quality management systems. Both initiatives were significant steps toward ensuring the safety, quality, and effectiveness of medical devices.

Over time, the FDA recognized the similarities between Part 820 and ISO 13485 and considered harmonizing the two to streamline compliance on a global scale. In 2018, the FDA began working on aligning Part 820 with the 2016 edition of ISO 13485.

In January 2024, the FDA moved closer to this goal by releasing the long-awaited final rule, which outlines new quality system requirements for medical devices. This final rule, now referred to as the Quality Management System Regulation (QMSR), updates the expectations of the FDA’s current good manufacturing practice (cGMP) to match the ISO 13485:2016 standard. The aim is to simplify compliance while reducing long-term costs for the industry.

With a two-year transition period granted by the FDA, what will the final QMSR entail? How will you know if your company is ready when the new rule comes into full effect? This Q&A explores the key aspects of the harmonization and provides guidance to help ensure compliance with the new QMSR standards.