The US FDA published its final rule aligning U.S. quality regulations (QMSR) to international standards (ISO 13485)
The US FDA has released the eagerly awaited final decree on Quality Management System Regulation (QMSR), bringing its stipulations into alignment with the widely acknowledged International Organization for Standardization (ISO) criterion. The stakeholders in the industry have until February 2, 2026 to comply with this decree.
The US FDA has released the awaited final decree on Quality Management System Regulation (QMSR), bringing its stipulations into alignment with the widely acknowledged ISO standard. The stakeholders in the industry have until February 2, 2026 to comply with these rules. It is very important note for the manufacturers willing to start with their devices market access in the USA.
This initiative seeks to foster uniformity in the regulatory anticipations for manufacturers of medical devices under diverse regulatory frameworks, thereby resulting in noteworthy cost savings for the sector.
Released on January 31, the ultimate ruling on QMSR revises the FDA’s extant anticipations for good manufacturing practices (CGMP) pertaining to medical devices within its quality system (QS) regulation to comply with ISO 13485:2016.
The FDA’s Center for Devices and Radiological Health (CDRH) places significant emphasis on advancing global harmonisation in device regulation. This effort, in turn, guarantees timely and uninterrupted access to safe, efficacious, and superior-quality medical devices worldwide. By aligning crucial elements of a medical device manufacturer’s quality management system with the international benchmark, the FDA aims to streamline compliance requisites across various regulatory authorities.
The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.
The FDA underscored the noteworthy parallels between the mandates in ISO 13485 and its QS regulation, ensuring a comparable degree of assurance regarding the compliance of medical technology manufacturers with regulatory expectations. The fresh decree maintains the ambit of the QS regulation while introducing revisions to numerous clauses.