The FDA Jan. 31 issued its long-awaited final rule amending the current good manufacturing practice (cGMP) requirements of the quality system (QS) regulation, 21 C.F.R. Part 820, to align more closely with the international consensus standard for device quality, ISO 13485, thereby converging with the quality management system (QMS) requirements established by other countries.

The agency set a Feb. 2, 2026, effective date for the final rule, which establishes the new Quality Management System Regulation (QMSR). The final rule was published in the Federal Register on Feb. 2, 2024 (89 Fed. Reg. 7496).

A proposed rule to amend the QS regulation was issued in February 2022 (87 Fed. Reg. 10119).

The final rule incorporates International Organization for Standardization (ISO) 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, Third Edition 2016-03-01, by reference, It also establishes additional requirements and makes conforming edits to clarify the device cGMP requirements.

“This final rule is the latest action taken by the FDA to promote global harmonization in device regulation to help assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices both at home and abroad,” said Dr. Jeffrey E. Shuren, director of the FDA's Center for Devices and Radiological Health, when the final rule was issued.

“By harmonizing key areas of a medical device manufacturer’s quality management system (QMS) with the international standard,” Shuren added, “the FDA is streamlining actions device manufacturers must take to meet requirements by multiple regulatory authorities.”

New Requirements ‘Substantially Similar’

The FDA said that it had determined that the requirements of ISO 13485 “are, when taken in their totality, substantially similar to the requirements of the QS regulation, providing a similar level of assurance in a firm’s QMS 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).

The agency said that in the final rule it was “retaining the scope of the QS regulation” while amending many of its provisions.

Among the changes are a change of the name of the regulation from the Quality System Regulation to the Quality Management System Regulation. Other changes are intended to ensure that incorporating ISO 13485 by reference does not create inconsistencies with other FDA requirements.

The final rule also makes conforming edits to 21 C.F.R. Part 4 to clarify the QMS requirements for combination products. The FDA said that the edits do not change the cGMP requirements for those products.

Benefits of the Final Rule

Until now, device manufacturers registered with the FDA have been required to comply with Part 820 while manufacturers in many other jurisdictions as well as U.S. manufacturers that export devices have been required to comply with ISO 13485.

“The redundancy of effort to comply with two substantially similar requirements creates inefficiency,” the FDA said in the preamble to the final rule.

“FDA expects that the aligned requirements will reduce the burden on industry to prepare documents and/or records for inspections and audits,” the agency said. “In addition, the final rule will result in establishments conducting internal audits and management reviews based on aligned requirements as opposed to auditing and assessing separately to comply with the requirements of the previous QS regulation and ISO 13485 individually. The harmonization of requirements will reduce training costs of industry in that internal training can now cover an aligned set of requirements.”

Even though the requirements under the QS regulation “are effective and substantially similar to those in ISO 13485,” the FDA said, “incorporating ISO 13485 by reference will further the agency’s goals for regulatory simplicity and global harmonization and should reduce burdens on the regulated industry overall.”

The agency estimated that the new QMSR will save the device industry between $532 million and $554 million per year. The final rule also will provide “quicker access to newly developed medical devices for patients, leading to improved quality of life of the consumers.”

More cost savings will result from aligning Part 820 with other related programs, according to the FDA.

Changes to Proposed Rule

The agency noted that after considering the comments received on the proposed rule, it modified the proposed rule “primarily for clarity and accuracy and to improve understanding of the QMSR.”

The FDA added that on its own initiative it had made minor technical changes “to further align the QMSR with requirements of the FD&C Act and its implementing regulations.”

In the preamble to the final rule, the agency listed 18 “more significant revisions, additions and removals” that it had made to revise the proposed rule.

The agency has posted a set of frequently asked questions and answers about the QMSR final rule.