FDA Amends Medical Device Regulations to Align With Quality Management System Rule
December 04, 2025
December 04, 2025
WASHINGTON, Dec. 4 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final rule making technical amendments to medical device regulations to ensure consistency with the Quality Management System Regulation (QMSR).
These changes are editorial and non-substantive, meaning they do not impose any extra requirements on affected parties.
The QMSR Final Rule, issued on Feb. 2, 2024, modernized the device current good manufact . . .
These changes are editorial and non-substantive, meaning they do not impose any extra requirements on affected parties.
The QMSR Final Rule, issued on Feb. 2, 2024, modernized the device current good manufact . . .