UDI and FDA’s New QMSR Inspection Process

On February 2, 2026, the U.S. Food and Drug Administration’s (FDA) Quality Management System Regulation (QMSR) officially went into effect—marking a major modernization of FDA’s approach to quality system oversight for medical device manufacturers.

At the same time, FDA published its updated compliance program (CP) manual, “Inspection of Medical Device Manufacturers (CP 7382.850)”, which describes how FDA investigators will conduct inspections under QMSR. (Reference: FDA Compliance Program Manual CP 7382.850)

This updated inspection program reflects FDA’s broader shift toward alignment with ISO 13485, and it introduces meaningful changes to what inspectors will prioritize and how they will assess compliance.

One key takeaway for manufacturers: UDI is now clearly embedded in FDA’s inspection approach—and companies should expect more structured UDI review during risk-based inspections.

How FDA Inspections Are Organized Under QMSR

The new CP manual organizes inspections into:

Six Quality Management System (QMS) Areas

1. Change Control
2. Design and Development
3. Management Oversight
4. Measurement, Analysis, and Improvement
5. Outsourcing and Purchasing
6. Production and Service Provision

Four Categories of Other Applicable FDA Requirements (OAFRs)

1. Medical Device Reporting (MDR)
2. Corrections and Removals
3. Tracking
4. Unique Device Identification (UDI)

UDI is an explicit OAFR category—FDA has made UDI a defined inspection component with specific review steps and enforcement considerations.

What FDA’s Compliance Program Says About UDI

FDA established the Unique Device Identification (UDI) system under section 519(f) of the FD&C Act to improve the identification and traceability of medical devices sold in the U.S. from manufacturing through distribution and use.

FDA highlights several UDI benefits, including:

• simplifying the integration of device use
• faster identification of devices associated with adverse events
• improved recall efficiency and execution
• better FDA safety communications
• stronger postmarket surveillance

The UDI final rule requires device labelers (typically manufacturers) to:

1. include a UDI on device labels and packages (and in some cases directly on the device),
2. submit device information to GUDID, the Global Unique Device Identification Database, and
3. use the device’s UDI in various Quality System processes.

FDA’s public-facing AccessGUDID database makes device data visible and searchable—so UDI accuracy is both a regulatory and reputational issue.

Where UDI Shows Up in QMSR Requirements

The CP manual connects UDI requirements to QMSR/ISO alignment by referencing several UDI-specific touchpoints in 21 CFR Part 820, including:

• 21 CFR 820.10(b)(1): Manufacturers must document a system to assign UDI in accordance with 21 CFR 830 (ISO 13485 Clause 7.5.8)
• 21 CFR 820.35(a)(3): Manufacturers must record UDI/UPC and other device identification (ISO 13485 Clause 8.2.2)
• 21 CFR 820.35(b)(2): Servicing records must include UDI/UPC where applicable (ISO 13485 Clause 7.5.4)
• 21 CFR 820.35(c): Manufacturers must record UDI for each batch/batch of devices (ISO 13485 Clauses 7.5.1, 7.5.8, 7.5.9)
• 21 CFR 820.45(a)(1): Labeling/packaging must be examined for accuracy prior to release—including correct UDI/UPC (ISO 13485 Clause 7.5.1)

Bottom line: UDI compliance is now tied directly into quality system controls—and is expected to be implemented consistently across labeling, traceability, complaints, adverse event reporting, and servicing.

UDI Also Appears in Other FDA Requirements

UDI will also be evaluated in other inspection areas, including:

• Medical Device Reporting (MDR) — 21 CFR 803: FDA will verify MDRs include the UDI appearing on the device label/package when known.
• Corrections and Removals — 21 CFR 806: FDA will verify correction/removal reports include the UDI that appears on the device labeling.

What FDA Investigators Will Review for UDI

The CP manual states FDA will evaluate UDI during all risk-based inspections (except PMA preapproval inspections). Investigators may:

• confirm the UDI lis available in:
  • plain text, and
  • AIDC format, and verify scan quality and readability
• assure that the information in AccessGUDID fields (including DI Information, Device Characteristics, Alternative/Additional Identifiers, and Customer Contact) is complete and matches the labeling information
• verify discontinued products have been appropriately updated:
• confirm claimed exceptions/alternatives are properly supported
• review labeling and label control procedures to ensure UDI requirements are included and align with the Medical Device File (MDF)
• verify UDI capture in:
  • device/batch records
  • complaint handling
  • servicing reports ( as applicable)

Enforcement Considerations: UDI Violations Can Escalate

FDA notes that CDRH should consider action when UDI violations are identified. Examples include:

• failure to ensure devices required to bear UDI are properly labeled (21 CFR 801.20)
• failure to submit required information to GUDID (21 CFR 830.300)

If a manufacturer has already received a Warning Letter for UDI violations and continues to fall short, FDA may recommend administrative or judicial action.

Prepare Now: QMSR Inspections Will Put UDI Under the Microscope

Under QMSR, UDI is no longer a standalone compliance task—it is a measurable inspection target tied to quality system effectiveness, traceability, complaint handling, and postmarket execution. With FDA’s updated inspection playbook now in effect, manufacturers should expect investigators to validate not only whether UDI exists, but whether it is accurate, controlled, documented, and consistently implemented across systems and records.

That level of readiness requires more than a barcode. It requires a UDI program that is inspection-ready end-to-end—from label control procedures and device master records to AccessGUDID alignment and postmarket processes.

How USDM Can Help

USDM helps manufacturers build and strengthen UDI programs that stand up to FDA scrutiny by providing:

• UDI strategy and program design
• GUDID/AccessGUDID submission support
• Data validation and labeling alignment (DI/PI integrity checks)
• UDI remediation and inspection readiness assessments
• Process and procedure updates aligned to QMSR and ISO 13485
• Ongoing UDI operations support for sustained compliance

If you’re preparing for QMSR inspections—or want confidence that your UDI program will hold up during FDA review—USDM can help you close gaps quickly and build a UDI foundation that supports both compliance and operational efficiency.

Ready to strengthen your UDI program? Contact USDM to schedule a UDI readiness assessment.