On February 2, 2026, the U.S. Food and Drug Administration issued the Compliance Program Manual 7382.850. The comprehensive document serves as an operational guide for FDA personnel (Field and Center staff) to conduct inspections and enforcement activities, while at the same time acting as a strategic resource for medical device manufacturers, providing transparency on the methodologies and criteria the FDA uses when inspecting manufacturers and importers of Medical Devices, both in the United States and internationally.
This program consolidates and updates previous protocols, fully replacing both CP 7382.845 (commonly known as QSIT) and CP 7383.001 related to PMA inspections. The manual applies to the new Quality Management System Regulation (QMSR), effective February 2, 2026, which replaced the previous Quality System Regulation (QSR, 21 CFR Part 820) and incorporates by reference the international standard ISO 13485:2016.
Key Points in QMSR Evaluation
- A Paradigm Shift: From “Isolated Subsystems” to TPLC
The new CP 7382.850 marks the definitive move away from evaluating isolated subsystems, typical of the previous QSIT model. The FDA now adopts the Total Product Life Cycle (TPLC) approach: inspections become an integrated assessment that follows the product throughout its entire life cycle, ensuring that design, manufacturing, and post-market processes are interconnected. - Focus on Risk Management
Risk management is no longer limited to the design phase but must involve the entire quality system, from purchasing to production, through post-market activities, including cybersecurity, which is particularly relevant for “cyber devices” under Section 524B of the FD&C Act. Inspectors will verify that daily operational decisions are effectively guided by risk analysis. - Increased emphasis on Post-Market Data
Post-Market Surveillance plays a key role in evaluating the effectiveness of the quality system. It includes complaint handling, the collection and analysis of post-market data, and mandatory reporting under federal regulations. Key sources of information include:
- Medical Device Reporting (MDR, 21 CFR 803): mandatory reporting of deaths, serious injuries, or device malfunctions.
- Reports of Corrections and Removals (21 CFR 806): management and reporting of field corrections or recalls.
- Service and complaint data: information collected from users or customer service that may indicate risks or safety issues.
Inspectors will verify that this information is effectively analyzed and integrated into risk management, helping to identify potential risks and guide operational decisions throughout the device’s life cycle.
Final considerations on the manual
Compliance Program 7382.850 represents the FDA’s official guidance for conducting inspections of medical device manufacturers and importers, both domestic and international.
It integrates QMSR evaluation with a Total Product Life Cycle (TPLC) approach, highlighting the importance of risk management and post-market surveillance as tools to prevent risks to patients and users.
In addition to the QMSR, inspections also consider Other Applicable FDA Requirements (OAFR), such as UDI and Medical Device Tracking, to ensure safety, traceability, and full regulatory compliance.
Studying CP 7382.850 provides manufacturers with a competitive advantage, allowing them to approach inspections proactively and integrate best practices throughout the device life cycle.
>>> Thema supports manufacturers in regulatory strategies to access the U.S. medical device market.
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