FDA QMSR Webinar Answers Common Industry Questions About the New Rule

As the February 2, 2026, effective date for the FDA’s Quality Management System Regulation (QMSR) draws near, many medical device manufacturers are asking the same question: What does this really mean for my quality system in practice?

To help answer that, the FDA’s Center for Devices and Radiological Health (CDRH) hosted a dedicated industry webinar in mid-December 2025, featuring a live panel of FDA quality, compliance and inspection leaders.

While the presentation covered QMSR fundamentals, several practical insights came during the moderated question-and-answer session, where FDA officials addressed common points of confusion from manufacturers as they prepare for the transition.

Below is a recap of Q&A topics and key takeaways from that discussion and what they signal for organizations preparing for transition to the new regulation.

Contents

When does FDA start enforcing QMSR?

Does ISO 13485 certification equal QMSR compliance?

Will existing GMP exemptions still apply?

Is the FDA incorporating other ISO standards, such as ISO 14971?

What happens if ISO 13485 is revised?

Will there be a new FDA inspection process?

What does “Reserved” mean in the published regulation?

Does specific identifying information need to appear on each batch or lot of a product?

Are the requirements of 21 CFR 820.180 and .198 in the QSR still applicable?

Will an Investigational Device Exemption (IDE) that has been approved under 21 CFR Part 812 still require compliance with Design Controls?

Additional key takeaways from the FDA

What this means for quality teams

When does FDA start enforcing QMSR?

The FDA confirmed that inspections conducted on or after February 2, 2026, will assess compliance against the QMSR, not the current Quality System Regulation (QSR). The existing Quality System Inspection Technique (QSIT) will be retired and replaced with a new inspection approach aligned to QMSR requirements.

What this means for manufacturers:

Quality systems must be fully transitioned by the effective date. Partial alignment or “ISO-only” readiness will not be sufficient during an FDA inspection.

Does ISO 13485 certification equal QMSR compliance?

No, ISO 13485 certification alone does not guarantee QMSR compliance. And the reverse is also true. The FDA emphasized two key points:

• FDA inspections do not result in ISO 13485 certification.

• Manufacturers must comply with all applicable provisions of the QMSR, the FD&C Act and other FDA regulations regardless of ISO certification status.

ISO 13485 provides the foundation for QMSR changes, but the new rule includes FDA-specific expectations that must be addressed directly within your quality system.

Will existing GMP exemptions still apply?

Yes, current GMP exemptions remain in effect under QMSR. The FDA clarified that exemptions established under existing classification regulations are not overridden by the new rule. The Code of Federal Regulations will be updated to reflect QMSR terminology, but existing exemptions continue to apply. 

Is the FDA incorporating other ISO standards, such as ISO 14971?

No. While ISO 13485 references other standards, such as ISO 14971 for risk management, QMSR only incorporates ISO 13485:2016 and Clause 3 of ISO 9000:2015 by reference. Other standards referenced or listed as a source in ISO 13485 remain voluntary, unless otherwise required by regulation.

What happens if ISO 13485 is revised?

The FDA confirmed that ISO 13485:2016 will remain unchanged until at least 2030. If future revisions occur, the FDA will evaluate the impact and determine whether updates to QMSR are needed through formal rulemaking.

Will there be a new FDA inspection process?

The QMSR retains and strengthens labeling and packaging requirements. The FDA confirmed:

• Labeling must be examined for accuracy (UDI, expiration dates, instructions, etc.)
• Procedures must be documented to prevent mix-ups during packaging operations
• Automated inspection is allowed, but human oversight is still required, including review of representative samples
• A designated individual must examine, at a minimum, a representative sampling of all labels that have been checked by automated readers.

What does “Reserved” mean in the published regulation?

The FDA indicated that sections labeled “reserved” are intentionally left blank and no action is needed. This is a standard regulatory practice designating space the FDA may use for future requirements and is not missing or omitted content

Does specific identifying information need to appear on each batch or lot of a product?

Yes, there is additional information that must be included for control of records. Section 820.35 requires that for each medical device or batch of medical devices, the Unique Device Identification (UDI) must be recorded. This is in addition to complying with the requirements of ISO 13485:2016 standard in Clauses 7.5.1, 7.5.8, and 7.5.9. This ensures comprehensive traceability and accountability for every device that is produced.

Are the requirements of 21 CFR 820.180 and .198 in the QSR still applicable?

Yes, these general requirements remain applicable, although they will no longer be numbered. Manufacturers can meet the requirements set forth in those sections by complying with 820.35 for control of records, and the records and complaint handling portions of ISO 13485.

Will an Investigational Device Exemption (IDE) that has been approved under 21 CFR Part 812 still require compliance with Design Controls?

Yes, IDEs approved under 21 CFR Part 812 will be required to comply with what will now be referred to as Design and Development requirements in the QMSR.

Additional key takeaways from the FDA

While the Q&A reveals common issues from industry, the FDA also outlined key takeaways about the new QMSR.

• When terminology differs, ISO definitions are superseded by definitions in the FD&C Act, followed by terms defined in the QMSR, then in other existing FDA regulations.

• QMSR applies to all finished medical devices intended for human use, including entities performing related functions, such as contract sterilization, relabeling, installation or specification development. These entities are expected to maintain a compliant QMS.

• QMSR governs the full device lifecycle, including design, manufacturing, packaging, labeling, storage, installation and servicing, reinforcing the FDA’s expectation that quality be managed end-to-end.

• Supporting guidance and inspection updates are forthcoming. The FDA will update compliance programs, guidance documents and internal operating documents, such as SOPs, instructions and templates, to support consistent implementation and oversight under QMSR.

How to prepare for QMSR compliance

Consistent with industry and supporting services, the FDA recommended practical preparation steps:

• Understand the regulatory changes
• Conduct a gap analysis against QMSR and ISO 13485
• Update processes and procedures
• Train personnel
• Monitor implementation effectiveness

What this means for quality teams

The FDA’s QMSR webinar reinforced the message that QMSR is not just a rebranding of ISO 13485. It represents a shift toward globally harmonized quality expectations, with FDA-specific accountability included.

QT9 Software and QT9 QMS can help quality teams move beyond QMSR interpretation and into execution. Whether you are performing a gap analysis, aligning ISO and FDA requirements, or preparing for the new inspection model, having an integrated, audit-ready quality management system is critical.

Let QT9 show you how we support MedTech and medical device manufacturing.