German medtech MDR to FDA bridge.
The corridor view. What carries from an MDR file into a US 510(k) submission, and what has to be rebuilt for FDA.
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The US FDA regulation establishing current Good Manufacturing Practice (cGMP) requirements for the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of finished medical devices.
The Quality System Regulation, codified at 21 CFR Part 820, sets out current Good Manufacturing Practice (cGMP) requirements for finished medical devices marketed in the United States. The regulation covers design controls, document controls, purchasing controls, identification and traceability, production and process controls, acceptance activities, nonconforming product, corrective and preventive action (CAPA), labelling and packaging controls, handling, storage, distribution, installation, records, servicing, and statistical techniques. Compliance applies to manufacturers of finished devices intended for commercial distribution.
FDA inspections are conducted under the Quality System Inspection Technique (QSIT), a structured approach focusing on the four major subsystems of management, design controls, CAPA, and production and process controls. Observations of non-compliance are issued on Form FDA 483. Significant or unresolved deviations can escalate to FDA Warning Letters, import alerts, or consent decrees. Foreign manufacturers shipping to the US are subject to FDA inspection at their manufacturing site.
QSR is in the process of being harmonised with ISO 13485:2016 under the Quality Management System Regulation (QMSR). The QMSR final rule was published by FDA on 2 February 2024 and is effective 2 February 2026. The QMSR incorporates ISO 13485 by reference while retaining specific FDA requirements that ISO 13485 does not address, including labelling, complaints, records, and adverse-event reporting links to 21 CFR Part 803. From the effective date, the QMSR replaces Part 820 in its current form, although references to 21 CFR Part 820 remain in widespread industry and FDA usage during the transition.
For European medtech manufacturers operating an ISO 13485-certified quality management system, the QSR-to-QMSR harmonisation reduces, but does not eliminate, the gap between EU and US quality requirements. ISO 13485 certification is not a substitute for FDA inspection authority, and the FDA-specific elements of QMSR, including 21 CFR Part 803 medical device reporting and 21 CFR Part 806 corrections and removals, remain US-specific. The corridor mechanics are detailed in the German medtech MDR-to-FDA bridge pillar.
For firms preparing for a first FDA inspection, the gap analysis between an existing ISO 13485 QMS and FDA-specific requirements is a defined piece of work that determines inspection readiness.
The corridor view. What carries from an MDR file into a US 510(k) submission, and what has to be rebuilt for FDA.
Read the pillar →Medtech and biotech operators in front of US procurement, payers, and the regulatory gate.
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