FDA Medical Device Inspections: What Changed and Why It Matters

Date

February 6, 2026

Category

US Regulations

Description

FDA’s medical device inspection framework has moved from the legacy QSIT guidance model to a risk-based inspection program described in Compliance Program 7382.850. The change is not just a reformatting of inspection checklists. It changes how the FDA plans inspection scope, how investigators move through the quality system, and what manufacturers must be ready to demonstrate during an inspection.

Under the QSIT guide, investigators are instructed to use a “top-down” subsystem approach. The guide describes seven subsystems with related satellite programs, and identifies four major subsystems as the foundation of a firm’s quality system: Management Controls, CAPA (with MDR, Corrections and Removals, and Tracking as satellites), Design Controls, and Production and Process Controls. The approach begins with confirming the firm has defined and documented procedures for a subsystem, followed by sampling records to evaluate implementation. The guide also acknowledges a “bottom-up” method that starts from specific quality problems and works back through the system, but positions the top-down subsystem review as the inspection structure.

Under the new program (7382.850), the FDA states inspections are risk-based and aligned with the QMSR’s emphasis on risk and linked processes. The inspection process organizes QMSR requirements into six QMS Areas and four Other Applicable FDA Requirements (OAFRs). Investigators are directed to focus on risks to the patient and/or user, and to recognize that evaluating one requirement may necessitate evaluation of related requirements across the QMS because processes are integrated.

In practice, this means the inspection scope is less “subsystem standard” and more adaptive. Planning and team composition are to consider product and process complexity, prior deficiencies, and new risk indicators such as recalls and MDR increases. The program also explicitly frames expectations for top management to ensure requirements are met through integration of QMS processes and a culture of quality.

For manufacturers, inspection readiness now depends on demonstrating that the QMS operates as an integrated, risk-informed set of processes, not only that procedures exist, but also that records are complete. CAPA, complaint handling, design and development, production controls, and other activities are more likely to be assessed in terms of linkage, risk rationale, and effectiveness. Multi-site organizations should also expect more scrutiny of how QMS responsibilities are distributed across locations, because the program directs the FDA to consider whether additional domestic or foreign sites should be inspected when key QMS functions or manufacturing responsibilities are split across locations.

Quick Reference: Inspection Approach Comparison

Area	QSIT Guide (Legacy)	Compliance Program 7382.850 (New)
Primary organizing model	Subsystem inspection guidance (top-down), with seven subsystems and satellites, and four major subsystems used as the inspection foundation.	Risk-based inspection program aligned to QMSR, organized into six QMS Areas and four OAFRs.
How scope is set	Structured subsystem coverage with inspectional objectives, decision flow charts, and sampling tables.	Planned and expanded based on patient/user risk and risk signals (e.g., recalls, MDR increases, prior deficiencies), plus product/process complexity.
Risk emphasis	Risk is not the organizing construct; focus is on evaluating compliance within subsystems using procedures and sampled records.	Risk management and risk-based decision making are explicit evaluation targets, with inspection focus on risk to the patient/user.
CAPA positioning	CAPA is a major subsystem and a logical “jumping-off” point to postmarket satellite programs (MDR, Corrections and Removals, Tracking).	CAPA is evaluated in the context of integrated QMS processes and risk, including depth of investigation and verification of effectiveness when following up on prior issues.
Management responsibility	Management Controls is a major subsystem within the inspection model.	Program explicitly cites top management responsibility to integrate QMS processes and support a culture of quality.
Multi-site/global considerations	Primarily site-based subsystem inspection approach.	Program directs consideration of cross-site QMS overlap or segregation of responsibilities, and may drive inspection of additional sites.