Quality and Compliance (Medical Devices)

Update: February 2, 2026

The Quality Management System Regulation (QMSR), became effective on February 2, 2026, amending the device current good manufacturing practice (CGMP) requirements of 21 CFR part 820 and incorporating by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.

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 is responsible for assuring medical devices available in the United States are safe and effective throughout their total product lifecycle. In meeting this charge, the FDA promotes the development and production of high-quality medical devices. The FDA also recognizes that proper maintenance, repair, and servicing of medical devices is critical to maintaining the safe, effective, and reliable performance of devices used in the health care system.

The FDA has established Quality Management System Regulation (QMSR) addressing device design and development as well as current good manufacturing practices. The FDA’s QMSR also address complaint investigations and other means of surveilling device performance. The FDA works with manufacturers to help them achieve regulatory compliance, and takes enforcement action as appropriate.

The FDA takes enforcement action to bring medical device manufacturers into compliance when manufacturers may not be complying with medical device laws. However, relying on enforcement actions alone does not necessarily lead to or result in manufacturers focusing on improving the quality of their products.

To promote quality design and development and manufacturing practices, and to provide options to demonstrate compliance, the FDA has implemented programs such as the Case for Quality. Through such initiatives, the FDA works with industry and other stakeholders to identify barriers to medical device quality and develop innovative ways to remove those barriers, affording patients access to high-quality medical devices.

FDA's Medical Device Quality and Compliance Tools