In today’s blog, we will explore about US FDA Quality Management System Regulation (QMSR). Whether you’re a startup or established manufacturer, understanding the US FDA Quality Management System Regulation (QMSR) is vital for ensuring regulatory compliance and bringing your product to the market

It is also important for Medical Device QA/RA Professionals to know in detail about US FDA Quality Management System Regulation (QMSR)

Let’s get into the topic.

US FDA QUALITY MANAGEMENT SYSTEM REGULATION (QMSR)

The Medical Device Manufacturers must establish and maintain a QMS that aligns with the FDA’s updated Quality Management System Regulation (QMSR). This QMSR ensures that every medical device product meets the relevant performance, safety & quality requirements consistently.

The quality expectations of FDA regulated industries including foods, drugs, biologics, and medical devices are traditionally known as current good manufacturing practices (CGMPs). For medical devices, the CGMP requirements originally rooted in section 520(f) of the Federal Food, Drug, and Cosmetic Act, were historically defined under 21 CFR Part 820.

Recently, the FDA has finalized amendments to the device CGMP framework. These amendments modernize 21 CFR Part 820 to harmonize it with international practices. In this harmonization effort, the FDA has formally adopted ISO 13485:2016, an internationally recognized standard for medical device quality systems, by incorporating the ISO standard directly into the regulation. This alignment by FDA brings U.S. expectations in line with global medical device manufacturing and lifecycle management practices.

Along with integrating ISO 13485, the FDA has added clarifications to ensure that references within the standard do not conflict with broader FDA regulatory requirements and FDA have also refined certain terminologies. The revised rule, now officially titled as Quality Management System Regulation (QMSR), which became effective on February 2, 2026. In addition to ISO 13485, the rule incorporates key terminology from ISO 9000:2015, Clause 3, supporting consistent interpretation of quality management concepts.

The FDA has updated its inspection approach to support this transition. The Quality System Inspection Technique (QSIT) is no longer been used from February 2, 2026. Instead, FDA now follows the Inspection of Medical Device Manufacturers Compliance Program (7382.850), which implements a risk‑based, Total Product Life Cycle (TPLC) inspection model in alignment with ISO 13485:2016. At the same time, earlier inspection documents such as 7382.845 and 7383.001 were formally withdrawn by FDA.

US FDA QUALITY MANAGEMENT SYSTEM REGULATION (QMSR)

Major Differences Between QSR and QMSR

The former Quality System Regulation (QSR) included Subpart A – Subpart O. The revised QMSR streamlines the structure to just Subpart A and Subpart B, with many of earlier Subparts in QSR replaced by ISO 13485:2016

Subpart A — General Provisions

820.1 Scope

The overall applicability of the QMSR remains consistent with the previous QSR.

820.3 Definitions

Many QSR terms such as Device Master Record (DMR), Device History Record (DHR), and Design History File (DHF) have been removed in QMSR. While these terms are no longer used, medical device manufacturers must still maintain comparable documentation under ISO 13485:2016, which requires medical device files, design and development records, and production documentation.

The QMSR introduces five definitions not found in ISO 13485 or ISO 9000, covering:

Manufacturer
Rework
Organization
Safety and Performance
Implantable medical device

820.5 [Reserved]

820.7 Incorporation by Reference

This section of QMSR formally incorporates standards ISO 13485:2016 and ISO 9000:2015 Clause 3.

820.10 Requirements for a Quality Management System (QMS)

ISO terminology replaces “Design Controls” with “Design and Development,” though the terminology has been changed, applicability to U.S. medical devices remains similar to the former QSR.

Section 820.10 includes:

(a) Documentation of the Quality Management System

Medical Device manufacturers must document their full QMS in accordance with ISO 13485 and QMSR specific requirements.

(b) Applicable Regulatory Requirements

ISO 13485 refers to “applicable regulatory requirements” in many clauses without specifying expectations. In the U.S., medical device manufacturers must interpret “applicable regulatory requirements” by referencing 820.10(b), which identifies the need to follow additional FDA regulations, such as:

21 CFR 803 – Medical Device Reporting
21 CFR 806 – Corrections and Removals
21 CFR 821 – Device Tracking
21 CFR 801 – Labeling
21 CFR 830 – Unique Device Identification
21 CFR 807 – Establishment registration and listing
Premarket requirements (510(k), De Novo, PMA)

(c) Establishing, Implementing, and Maintaining the QMS

Medical device manufacturers must build, execute, and continuously maintain an effective QMS.

(d) Interaction With ISO 13485

This subsection 820.10 (d) clarifies how QMSR supplements ISO 13485 standard, especially where additional FDA specific expectations apply.

Subpart B — Supplemental Provisions

820.20–820.30 [Reserved]

820.35 Control of Records

The FDA has added additional record control requirements which go beyond ISO 13485:2016 Clause 4.2.5. These additional provisions by FDA apply to documentation such as complaint file records and servicing records.

An important requirement in 820.35 is the inclusion of a device identifier information’s such as the UDI, UPC, or another unique marking for both individual devices and device batches. This is consistent with ISO 13485:2016 clauses addressing traceability and production.

The section also allows medical device manufacturers to label documents as “confidential” when submitting the documents to the FDA for regulatory reviews or inspections.

820.40 [Reserved]

820.45 Device Labeling and Packaging Controls

Although ISO 13485:2016 includes general labeling and packaging requirements, the FDA determined that additional information is necessary. Section 820.45 outlines detailed expectations for label inspection and control, complementing the standard ISO 13485 Clause 7.5.1.

Subpart C – Subpart O [Reserved]

The term “Reserved” in sections indicate that the FDA has removed previous QSR requirements in these areas and now expects medical device manufacturers to follow the corresponding ISO 13485:2016 clauses without additional FDA specific requirements.

The QMSR also removes the exemptions that previously limited FDA access to supplier evaluations, internal audits, management review records. All these records may now be reviewed by FDA during inspections.

Now I hope you have acquired some basic knowledge about the US FDA Quality Management System Regulation (QMSR). We will meet again with another valuable topic related to MedTech Quality & Regulatory, Biomedical Engineering, Medical Device, Healthcare.

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