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  1. Device Advice: Comprehensive Regulatory Assistance

Quality and Compliance (Medical Devices)

Update: January 31, 2024

The FDA issued the Quality Management System Regulation (QMSR) Final Rule, which amends the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating 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.
 
This final rule is the latest action taken by the FDA to promote consistency in the regulation of devices. This action is intended to harmonize the FDA’s CGMP regulatory framework with that used by other regulatory authorities.
 
The rule is effective February 2, 2026, two years after publication. Until then, manufacturers are required to comply with the QS regulation. 

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 System Regulations (QSR) addressing device design and validation as well as good manufacturing practices. The FDA’s regulations 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 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



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