On January 31, 2024, the U.S. Food and Drug Administration (FDA) issued a final rule that will promote consistency in the regulation of medical devices and will harmonize the regulatory framework for current good manufacturing practices.
In short, the FDA amended the good manufacturing practice requirements of the Quality System regulation to incorporate a 2016 standard adopted by the International Organization for Standardization (ISO). This standard, commonly known as ISO 13485, provides a comprehensive quality management system for the design and manufacture of medical devices to meet customer and regulatory specifications. The FDA's final rule, which will take effect on February 2, 2026, is an effort to synchronize key areas of medical device manufacturing with the ISO 13485 standard for quality management. This in turn will streamline the actions manufacturers must take to meet the requirements of multiple regulatory authorities.
Specifically, the impact of this final rule will depend on whether a company has already acquired ISO 13485 certification. For companies that already have this certification, there will be minimal to moderate changes necessary to comply with the new rule. However, for companies that do not already have the certification, this will require numerous changes to maintain compliance with the new rule. While the burden on previously non-ISO 13485 certified companies may be high with this final rule, the amendment will help assure that patients and providers have timely and continued access to safe, effective and high quality medical devices both at home and abroad.
The Current Good Manufacturing Practices are set under the Quality System regulation and codified in 21 CFR §820, Part 820. The new rule will amend Part 820 with incorporation of ISO 13485. The FDA stated it is "retaining the scope of the [Quality System] regulation" but amending "many of the provisions." While companies will have until February 2, 2026, to become compliant with the final rule, companies should begin to audit existing quality control procedures to ensure compliance with the amendment.
Up to now, domestic and international device manufacturers have faced the burden of meeting both U.S. regulations and international standards. This new rule is part of the FDA's broader effort to align domestic medical device quality requirements with international standards. This should reduce overall regulatory and compliance burdens for device manufacturers, both domestic and international, while at the same time enhancing the quality and safety of medical devices.
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