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US FDA Incorporates ISO 13485 Within Its QMSR Final Rule

The FDA final rule sets a two-year timeframe for medical device manufacturers to prepare for compliance to the Quality Management System Regulation that recognizes ISO 13485

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February 5, 2024

By Luana Zerafa

The US Food and Drug Administration (FDA) has issued a final rule that will recognize the ISO 13485 international medical device quality management standard as part the agency’s Quality Management System Regulation (QMSR), a major step toward greater harmonization of medical device regulations in the US with those of other markets and jurisdictions around the world.

Issued by the FDA on February 2, the QMSR Final Rule incorporating ISO 13485 becomes effective on February 2, 2026. The final rule follows a proposed rule from the agency in early 2022 targeting greater alignment between FDA’s erstwhile Quality System Regulation (QSR) and ISO 13485.

Manufacturers have two years to align internal processes and procedures, make appropriate changes within their organizations and update their documentation according to QMSR requirements.

Background on US QMS requirements for medical device manufacturers

The FDA has not undertaken a significant revision of the Code of Federal Regulations part 820 on the Quality Management System Regulation (QMSR) since the 1996 Final Rule  to simplify and streamline regulation to enhance global harmonization and reduce burdens on the medical device industry.

Now, the final QMSR rule brings US medical device quality management requirements closer in line with those of markets such as the European Union, Japan and Australia, where quality regulations are based more substantially on ISO 13485.

Summary of the QMSR final rule

Where possible, the FDA has accepted the incorporated ISO 13485 requirement without modification. However, the FDA confirms that compliance only with ISO 13485 does not fully satisfy the QMSR. FDA has added “limited” additional requirements to the QMSR where appropriate, and thus manufacturers must meet those additional QMSR requirements as well as to those set forth in ISO 13485. Some examples of these additional requirements include:

  • Requirements for control of records, especially around certain records that interface with other requirements in the FD&C Act such as records of complaints and servicing activities required by part 803, Medical Device Reporting and UDI in accordance with part 830, Unique Device Identification (specified in § 820.35 of the final rule);
  • Requirements related to labelling and packaging – FDA believes that ISO 13485 does not specifically address the inspection of labeling by the manufacturer, which is why FDA is retaining in this final rule requirements from the QMSR  that strengthen controls for labeling and packaging operations.

Manufacturers are no longer able to exempt certain records

One area that manufacturers may not welcome is the removal of the exception set out in the current § 820.180(c) related to management review records, internal quality audit reports and supplier audit reports. Under the current provision, manufacturers do not have to show these records to FDA inspectors. The FDA believes that this exception is not available to manufacturers inspected by other regulators or  audited by other entities (e.g., Medical Device Single Audit Program (MDSAP) auditing organizations), so to move closer towards global harmonization, FDA has removed this exception in the final rule.

In addition, commonly used terms such as “device master record (DMR),” “design history file (DHF)” and “device history record (DHR)” do not appear in ISO 13485 and are not separately defined in the QMSR final rule. Hence, US manufacturers will have to accept ISO 13485 and ISO 9000 terminology such as “medical device file (MDF).”

Concluding remarks

Moving forward, FDA intends to engage in a variety of implementation activities, including updating information technology systems, training of personnel, finalizing the inspection approach and assessing relevant regulations and other documents.

Luana Zerafa is Manager, Quality & Regulatory Affairs Program at Emergo by UL.


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