FDA issues draft guidance on QMSR information for premarket submissions

The US Food and Drug Administration (FDA) issued draft guidance for device makers that outlines its expectations for implementing the Quality Management System Regulation (QMSR). The guidance details the information that should be included to support Premarket Approval Applications (PMAs) and Humanitarian Device Exemption (HDE) applications, ensuring alignment with the QMSR.

FDA has indicated in its guidance that starting 2 February 2026, it will assess compliance with QMSR requirements.

According to Michael Heyl, an attorney with Hogan Lovells, the guidance represents a shift from the previous quality system requirements to the QMSR. Key changes include a strong emphasis on risk management and increased transparency. Under the new QMSR, FDA inspectors will now have the authority to review the results of both internal audits and supplier audits.

The QMSR will replace the FDA’s previous quality system regulation. Published in January 2024, the final QMSR rule updates the FDA's current Good Manufacturing Practices (CGMP) for medical devices under its Quality System (QS) regulation, aligning them with ISO 13485:2016. (RELATED: FDA issues QMSR final rule with 2-year transition period. Regulatory Focus 31 January 2024)

The guidance provides general information on establishing a quality management system (QMS) and outlines the basic expectations for its development. It covers management's responsibilities in creating, implementing, and documenting the organization's QMS.

The agency advises manufacturers to perform a gap analysis to help FDA evaluate documents and records that were created before the effective date of the QMSR in submissions.

Additionally, it details the necessary infrastructure to ensure product conformity and prevent product mix-up, as well as the control measures for monitoring and measuring equipment, which should include routine calibration or verification as applicable. The guidance also addresses the management of nonconforming products and the requirements for identifying and implementing necessary changes to maintain the effectiveness of the QMS.

As part of resource management, the guidance states that manufacturers must submit a diagram of their facility or facilities. This diagram should demonstrate that there is sufficient space to ensure the orderly handling of products, and prevent the mixing of various materials, including incoming materials, in-process batches, and scrapped items.

The guidance also specifies that manufacturers have procedures and documents in place to ensure that purchased products conform to the specified purchasing information.

FDA recommends that manufacturers provide a complete description of its QMS in a marketing submission. This summary should explain how the organization collects and monitors feedback regarding its ability to meet customer needs, as well as how it gathers data from both production and post-production activities. Additionally, it should detail how this feedback process is utilized in the product realization and improvement processes.

FDA also states in the guidance that manufacturers in their design and development plans should include a traceability matrix which traces design and development inputs to design and development outputs.

Heyl said that many device manufacturers are global and are already adhering to ISO 13485, so the impact on these manufacturers may be negligible. “A lot of companies do business overseas, so a lot of companies already have an ISO compliant 13485 quality system, so the lift to become compliant with QMSR would seemingly not be that significant particularly if [companies] are certified by a notified body to 13485. But there are some companies that have a QSR focused only quality system, then yes, now is the time to convert all of your processes to the new QMSR.”

Heyl said that one of the more significant changes is the guidance’s emphasis on risk management. The guidance places a “very, very heavy focus on risk management.” He added that “the [former] document was much less risk management based. There was one provision in the old guidance on designing validation where FDA said ‘describe your risk management program in the PMA’ … This one focuses on risk pretty much in every subsection, and using risk to justify your CAPA system, your design system, your supplier control system.”

Heyl said that another major change is that companies should also be prepared to share their internal and supply audits with the agency.

He said that under the former QSR system, “there were certain things that FDA would not ask for and would not look at during an inspection.” These include minutes from management reviews, internal audit files, or supplier audit records.

Heyl added that under the new system, manufacturers should be prepared to share these records. “We really want companies to give a hard look at their internal audits and give a hard look at their suppliers when they are auditing them or discussing issues at management meetings. Under the QMSR, FDA can now see all of those records, and they will be able to review them.”

“Previously [companies] did not have to show their internal records and now they will have to. That is a big difference … they can make an observation on a 483 based on those,” Heyl said.

Draft guidance

FDA issues draft guidance on QMSR information for premarket submissions

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