FDA Final Rule Harmonizes Medical Device Quality System Regulation with International Standard

Angelo Scangas – CEO & Chief Customer Officer

The FDA’s Quality Management System Regulation (QMSR) update represents a significant move towards harmonizing the Quality System Regulation (QSR) for medical devices with the international standard ISO 13485:2016. This harmonization aims to streamline regulatory requirements, ease the burden on device manufacturers, and ensure consistent safety and effectiveness in medical device manufacturing.

Key aspects of the QMSR include:

  • Incorporation of ISO 13485:2016: The QMSR integrates ISO 13485:2016 into 21 CFR Part 820, establishing requirements and clarifying concepts used in ISO 13485 to avoid inconsistencies with other FDA requirements​.
  • Terminology Changes: Terms like “design history file,” “device manufacturing record,” and “device history record” are replaced, aligning language with ISO 13485. Additionally, “safety and performance” will replace “safety and effectiveness” but with an assurance that this does not alter obligations regarding safety and effectiveness under the FD&C Act​​.
  • Scope and Applicability: The QMSR’s scope and applicability remain largely the same as the QSR, applying to finished medical devices, including specific Class I devices, with exemptions for certain components and raw materials​.
  • Risk Management and Internal Reviews: There is an enhanced emphasis on risk management throughout the product lifecycle, not just in design controls. Additionally, management review, quality audits, and supplier audit reports are now open to FDA inspection, eliminating the previous exception that protected such records from review​​.
  • Adjustments for ISO Certification and Labeling Controls: The QMSR does not require ISO 13485 certification for compliance, nor does it accept certification as a substitute for FDA inspections. The FDA also maintains its current QSR provisions for labeling controls, requiring human inspection for accuracy​​.

The final rule does not fundamentally alter the requirements for an effective quality system or the FDA’s inspection authority but introduces key provisions to be aware of, including the requirement for manufacturers to implement risk management practices throughout the product lifecycle. These updates necessitate that medical device manufacturers and importers modify their quality systems, processes, and record keeping to comply with the QMSR by the February 2, 2026, effective date​.

For firms already conforming with ISO 13485, especially in regions like the EU, Australia, Canada, and Japan, the transition might be less disruptive, necessitating only administrative and procedural updates for conformity. However, firms yet to implement ISO 13485 standards will need to undergo significant changes​​.This transition underscores the FDA’s ongoing efforts to harmonize its regulatory framework with international standards, aiming for a smoother and more unified global medical device market​​.

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