February, 2026: Silver Spring, MD USA. On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers Compliance Program: 7382.850. After February 2, 2026, the FDA will no longer use the following documents: Inspection of Medical Device Manufacturers (7382.845) and Medical Device PMA Preapproval and PMA Postmarket Inspections (7383.001).
The FDA has amended 21 CFR 820 by incorporating by reference the quality management system requirements of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016. The FDA has determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the QS regulation, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The rule amends the title of the regulation and establishes additional requirements that clarify certain expectations and certain concepts used in ISO 13485. These additions ensure that the incorporation by reference of ISO 13485 does not create inconsistencies with other applicable FDA requirements. This revised part 820 is referred to as the Quality Management System Regulation (QMSR), and became effective February 2, 2026.
The QMSR inspection process is described in the updated Inspection of Medical Device Manufacturers Compliance Program: 7382.850 . The updated Compliance Program (CP) also became effective on February 2, 2026. You may obtain a copy of the CP and plan your transition to the new QMSR here: https://www.fda.gov/media/80195/download
If you are not yet ISO 13485 certified, now is an excellent time to kill two birds with one stone – QMSR inspection readiness and ISO 13485 certification – for more information, please click here.