New FDA QMSR

On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026.

This regulation marks a pivotal transition from the guidelines previously stated in 21 CFR 820.5, forging a pathway toward an integrated approach that aligns with global standards. Now, under QMSR, Clause 4.1.1 of ISO 13485 and article 5 of Japanese QMS Act, requires organizations to document a QMS and maintain its effectiveness in accordance with the requirements of the standard and international regulations.