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FDA Amends Quality System Regulations for Medical Devices

In an effort to stay current with new and updated international standards, the U.S. Food and Drug Administration (FDA) has amended its quality system regulations applicable to the manufacture of medical devices.

In a Final Rule published in early February in the Federal Register, the FDA amended its current good manufacturing practice (CGMP) requirements for its quality system (QS) regulation applicable to medical device manufacturers. The amended requirements now incorporate by reference ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes. The FDA says that the change is part of its effort to harmonize its quality management systems requirements for medical devices with those adopted by other regulatory agencies.

The FDA’s final rule regarding the changes to its current CGMPs takes effect on February 2, 2026. Until then, device manufacturers must continue to comply with the FDA’s QS regulation.

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Read the FDA’s quality system regulation amendment as published in the Federal Register.

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