Q: What training will FDA staff do?Ī: FDA staff will be trained on the final rule, the revised inspection process and changes to associated policies and procedures. Q: What is the FDA doing to prepare for harmonization of the Quality System regulation with ISO 13485?Ī: The FDA intends to engage in a variety of implementation activities including, updating information technology systems, training FDA staff responsible for assessing compliance with medical device quality management system requirements, developing an inspection process, revising relevant regulations and other documents impacted by this rulemaking, and communicating and educating stakeholders, including affected FDA staff, on the change. This action, if finalized, will harmonize key areas of a device manufacturer’s Quality Management System and will more closely align the United States with many other regulatory authorities around the world. Q: Why is the FDA taking this action?Ī: The FDA is focused on advancing and continually improving the quality, safety, and effectiveness of medical devices to meet patient needs. These questions and answers provide clarity and do not introduce any new policies or modify any existing policies. This section provides answers to frequently asked questions related to the final rule. This action continues the FDA’s efforts to align its regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients. These edits do not impact the CGMP requirements for combination products. The FDA has made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products. This revised part 820 is referred to as the Quality Management System Regulation (QMSR). These additions ensure that the incorporation by reference of ISO 13485 does not create inconsistencies with other applicable FDA requirements. The rule amends the title of the regulation and establishes additional requirements that clarify certain expectations and certain concepts used in ISO 13485. 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). This rule amends 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. On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. When referring to the rule that is currently effective, the FDA uses the term “Quality System (QS) Regulation” or “QS regulation.” Because both the QMSR and the QS regulation are located in part 820, wherever possible, the FDA has used the terms “QS regulation” and “QMSR.” The revised part 820 is referred to as the Quality Management System Regulation (QMSR). In the Quality Management System Regulation final rule issued today, the FDA is amending the title of the regulation, and establishing requirements and provisions that clarify certain expectations and concepts used in ISO 13485:2016.
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