The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. In pursuit of this goal, the FDA has issued a final rule on ( 31 January 2024) Quality Management System Regulation (QMSR) to enhance the quality and safety of medical devices.
This guidance aims to provide clarity and consistency in implementing quality management principles across the medical device industry.
Key Changes Proposed:
Electronic Records and Signatures: The amendments propose updates to the requirements for electronic records and signatures. This includes clarifications on the use of electronic records and signatures by the FDA's requirements for electronic submissions.
Device History Record: There are proposed changes to the requirements for the Device History Record (DHR). The amendments aim to ensure that the DHR accurately reflects the device's manufacturing history, including the dates of manufacture, quantity manufactured, and primary identification label and labeling used for each production unit.
Supplier Controls: The amendments emphasize the importance of supplier controls in ensuring the quality and safety of medical devices. This includes requirements for evaluating and selecting suppliers, as well as establishing and maintaining supplier agreements.
Process Validation: Process validation is a critical aspect of ensuring the quality of medical devices. The proposed amendments guide process validation requirements, including the use of statistical techniques and sampling plans.
Design Changes: The amendments propose updates to the requirements for design changes to medical devices. This includes clarifications on when design changes require a new 510(k) submission or a premarket approval application (PMA).
These proposed amendments are significant for the medical devices industry. They aim to align the QSR with current industry practices and technological advancements, enhancing the quality and safety of medical devices. Manufacturers will need to review their quality systems and processes to ensure compliance with the proposed amendments once they are finalized.
The FDA is seeking public comments on the proposed amendments before finalizing them. The industry has until 2 February 2026 to come into compliance with the new rule and can continue to comply with requirements under the current QS regulation until then.
For more information and to submit comments on the proposed amendments, visit the Federal Register website.