US FDA Updates Compliance Program CP 7382.850 for Medical Device Inspections

On 2 February 2026, the US Food and Drug Administration (FDA) released an updated Compliance Program Manual (CP 7382.850) for the inspection of medical device manufacturers. This update coincides with the implementation of the Quality Management System Regulation (QMSR), which now incorporates ISO 13485:2016 by reference, marking a significant step toward regulatory convergence for medical device quality systems.

The new Compliance Program supersedes previous guidance and expands the FDA’s inspection scope to include a Total Product Life Cycle (TPLC) assessment, covering devices from design and development through postmarket surveillance.

Key Updates in CP 7382.850

Total Product Life Cycle (TPLC) Approach

Under the updated CP, FDA inspections will now assess compliance across the entire product life cycle, including:

• Design and development processes

• Manufacturing and production controls

• Postmarket monitoring and corrective actions

• Device labeling and Unique Device Identification (UDI) compliance

This TPLC approach emphasizes that manufacturers and importers are responsible for maintaining regulatory compliance at every stage of the device lifecycle.

Alignment with QMSR and ISO 13485:2016

The QMSR (21 CFR 820) now references ISO 13485:2016, providing FDA field staff and manufacturers with a framework for harmonised quality system requirements. This alignment helps manufacturers prepare for global regulatory expectations and supports international convergence in device quality management practices.

UDI, Labeling, and Identification Requirements

The updated CP emphasizes the importance of Unique Device Identification (UDI) compliance, ensuring that devices are adequately identified from manufacturing through distribution. Manufacturers and importers must maintain traceability and accurate device identification to support:

• Postmarket surveillance

• Recalls or corrections

• Regulatory reporting

Inspection and Enforcement Guidance

CP 7382.850 provides detailed instructions to FDA field and Center staff regarding inspections and enforcement related to:

• Medical Device Reporting (MDR) – 21 CFR Part 803

• Medical Device Tracking – 21 CFR Part 821

• Corrections and Removals – 21 CFR Part 806

• Establishment Registration and Device Listing – 21 CFR Part 807

• Unique Device Identification (UDI) – 21 CFR Parts 801 Subpart B and 830

• Premarket Approval (PMA) – relevant sections of the FD&C Act

The CP also incorporates considerations for manufacturers participating in the Medical Device Single Audit Program (MDSAP), linking audit findings to regulatory compliance oversight.

Implications for Manufacturers and Importers

Manufacturers and importers should be aware that:

• FDA inspections will now adopt a life-cycle-focused approach, increasing scrutiny on postmarket activities and design controls

• UDI compliance and device labeling are critical inspection points

• Non-compliance with registration, tracking, or reporting obligations can trigger enforcement or administrative actions

• Alignment with ISO 13485:2016 under QMSR helps demonstrate conformity and supports MDSAP readiness

Recommended Actions for Compliance

To prepare for inspections under CP 7382.850, manufacturers and importers should:

1. Review quality management systems against QMSR and ISO 13485:2016 requirements

2. Ensure all devices are accurately registered, listed, and labeled, with UDI requirements fully implemented

3. Maintain documented evidence of postmarket surveillance, tracking, and corrective actions

4. Align internal audit and training programs to reflect the TPLC inspection focus

5. Monitor and update compliance procedures in line with CP guidance to reduce regulatory risk

Early adoption and internal verification will help minimize inspection findings and enforcement actions.

Internal References

• FDA US Medical Device Registration

• US FDA QMSR Consulting for Medical Devices

External References

• FDA CP 7382.850 Compliance Program Manual (PDF)

• FDA Quality Management System Regulation (QMSR) Overview