FDA 21 CFR Part 820: Quality Management System for Medical Devices

Author: Maren Fichtner | October 2, 2026

Definition: What is FDA 21 CFR Part 820?

21 CFR Part 820 is the U.S. Food and Drug Administration (FDA) regulation governing the quality management system for medical devices placed on the market in the United States. As of February 2, 2026, it is known as the Quality Management System Regulation (QMSR): The previous, independently formulated Quality System Regulation (QSR) has been replaced by a direct reference to ISO 13485:2016, supplemented by additional FDA-specific requirements.

Publisher: U.S. Food and Drug Administration (FDA)

Current version: Quality Management System Regulation (QMSR)

To whom does FDA 21 CFR Part 820 apply?

The regulation applies to all manufacturers, importers, and suppliers who develop, manufacture, or distribute medical devices for the U.S. market – regardless of whether the company is based in the U.S. or abroad. European manufacturers seeking FDA clearance in addition to MDR compliance must also meet the requirements of the QMSR.

Overview of core requirements

ISO 13485 Basis: incorporation of management system requirements by direct reference
Design and development control: cocumented verification and calidation
Medical Device Reporting (MDR): requirement to report serious incidents to the FDA
Unique Device Identification (UDI): unique product identification for the U.S. market
Corrections and removals: FDA-specific requirements for recalls and corrective actions
Records and complaint files: record-keeping requirements that also apply to product categories otherwise exempt from CGMP

Differences from ISO 13485 and the MDR

Since the transition to the QMSR in 2026, the content of Part 820 has been closely aligned with ISO 13485:2016, but it is not identical to the standard: The FDA specifically adds provisions to areas it considers not fully covered by ISO 13485, such as incident reporting and recall procedures. ISO 13485 certification alone is therefore not automatically sufficient for QMSR compliance, but it significantly reduces the additional effort compared to companies that have previously operated exclusively under the old QSR. Compared to the European MDR, the QMSR remains a separate marketing authorization pathway with its own procedures (e.g., 510(k) or PMA instead of CE marking through a Notified Body). However, due to the shared ISO 13485 foundation, the substantive requirements of both regulatory frameworks have now converged much more closely than before.

Consequences of noncompliance

Without QMSR compliance, the FDA will deny marketing authorization for the U.S. market. For products that are already authorized, FDA inspections may result in warning letters, distribution restrictions, or – in severe cases – the revocation of authorization if nonconformities are found. Since the transition to QMSR requires significant adjustments to processes and documentation for many companies that previously operated exclusively under the old QSR, a timely transition is essential to avoid gaps during upcoming inspections.

Frequently asked questions about FDA 21 CFR Part 820

Is FDA 21 CFR Part 820 required by law?

Yes, as part of the U.S. Code of Federal Regulations, it is mandatory for access to the U.S. market and enforced by the FDA.

What has changed with the 2026 QMSR transition?

As of February 2, 2026, Part 820 refers directly to ISO 13485:2016, supplemented by additional FDA-specific requirements.

What is the difference between this and ISO 13485?

The QMSR incorporates ISO 13485 almost in its entirety, but supplements it with FDA-specific requirements such as incident reports and recalls.

What is the difference from the MDR?

Both require a quality management system, but use different approval processes—CE marking in the EU and FDA approval in the U.S.

Successfully implementing FDA 21 CFR Part 820

For manufacturers serving both the EU and U.S. markets, the greatest advantage of the transition to QMSR lies in the common ISO 13485 foundation: Once established, a fully documented quality management system can be used for both regulatory pathways. Connected worker platforms such as weasl automatically document work and inspection steps as the process unfolds, thereby providing a common, audit-ready database that meets both MDR and QMSR requirements.

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FDA 21 CFR Part 820