0Orientation & objectives
This course familiarizes participants with the regulatory changes FDA introduced over the period leading to 2 February 2026, the date the Quality Management System Regulation (QMSR) took effect. Its primary aim is to make those changes understood — above all the QMSR's incorporation of ISO 13485:2016 by reference — and what they mean in practice for an FDA inspection. A high-flux dialyzer manufacturer is used throughout as a running example to make the changes concrete; the example is illustrative, not the subject of the course.
Intended audience. Quality-management and quality-assurance consultants who are expert in ISO 13485, TÜV/notified-body audits, and MDSAP, but whose facilities have not been subject to an FDA inspection in approximately ten years. The course assumes command of ISO 13485 and concentrates on the requirements FDA adds on top of it.
Running example. High-flux dialyzers — classified by FDA as a high permeability hemodialysis system, 21 CFR § 876.5860, Class II, cleared via 510(k). Defining feature: a hemodialyzer membrane with an in-vitro ultrafiltration coefficient Kuf > 8 mL/hr/mmHg, removing fluid by convection in addition to diffusion, and supporting hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. The device recurs in the examples and job aids to ground each change; the regulatory changes themselves are the subject.
Learning objectives
On completion, a participant will be able to:
- Explain the QMSR and how it differs from the former Quality System Regulation, including the incorporation of ISO 13485:2016 by reference.
- Conduct a gap assessment of a quality management system against the QMSR's U.S.-specific requirements.
- Prepare a facility for a CP 7382.850 inspection of the high-flux dialyzer, including unannounced inspection scenarios.
How the course is structured
Seven content sections, each ending with short multiple-choice questions, followed by a final assessment.
| Format | Self-paced; approximately 90 minutes |
|---|---|
| Formative questions | 18 multiple-choice, distributed across sections (immediate feedback, not scored) |
| Final assessment | 30 multiple-choice questions; pass mark 80% |
| Currency | Reflects FDA regulations and guidance current as of June 2026 |
1What the QMSR changed (89 FR 7496)
The rule
| Title | Medical Devices; Quality System Regulation Amendments |
|---|---|
| Federal Register citation | 89 FR 7496 |
| Published | 2 February 2024 |
| Effective | 2 February 2026 (two years after publication) |
| Docket | FDA-2021-N-0507 (FR Doc. 2024-01709) |
| Proposed rule | 87 FR 10119 (23 February 2022) |
| Estimated net cost saving | ~ $507 million per year (at 7%) |
Incorporation by reference
The rule incorporates two documents by reference under § 820.7, giving them the full force and effect of law from the effective date:
- ISO 13485:2016 in full, including its Introduction (Clauses 0.1, 0.2, 0.4).
- ISO 9000:2015 Clause 3 (terms and definitions only).
ISO 14971 and other standards referenced inside ISO 13485 are not incorporated — they remain useful for application but are not legally required by the QMSR. Both incorporated documents are available read-only through the ANSI IBR portal at no cost.
Structural change to Part 820
Part 820 no longer states the quality system in approximately thirty stand-alone sections. It now consists of Subparts A and B only, with five active sections and the former Subparts C–O marked [Reserved]. The substantive requirements reside in ISO 13485:2016; Part 820 retains supplemental sections — most importantly § 820.35 (control of records) and § 820.45 (labeling and packaging controls).
Terminology changes that matter in an inspection
The QMSR adopts ISO 9000 vocabulary and removes Quality System Regulation record-type terms. The underlying records still exist; their names and governing clauses changed.
| Former QS Regulation term | Replaced by | ISO 13485 clause |
|---|---|---|
| Device master record (DMR) | Medical device file (MDF) | 4.2.3 |
| Design history file (DHF) | Design and development file | 7.3.10 |
| Device history record (DHR) | Batch record / medical device record | 7.5.1 |
| Quality system record (QSR) | Records per ISO 13485 | 4.2 |
| Management with executive responsibility | Top management (ISO 9000) | — |
Two further changes:
- "Establish" → "document." ISO 13485 Cl. 0.2 defines "document" to encompass establishing, implementing, and maintaining; the separate QS regulation definition of "establish" was removed.
- Terms retained or defined by FDA because the FD&C Act must control: organization = manufacturer; rework (action on nonconforming product before distribution — post-distribution action is a correction under Part 806); implantable medical device; safety and performance (= safety and effectiveness, only in ISO 13485 Cl. 0.1).
What FDA added beyond ISO 13485
ISO 13485 is jurisdiction-neutral. The QMSR adds U.S.-specific obligations through § 820.10 and the supplemental sections, and through other CFR parts: UDI (Parts 801/830), MDR (Part 803), corrections and removals (Part 806), tracking (Part 821), and labeling/packaging controls (§ 820.45). FDA harmonized to ISO 13485 rather than ISO 9001 because complaint handling and reporting to regulatory authorities are absent from ISO 9001:2015.