Does NIST Cybersecurity Framework 2.0 cover FDA Quality Management System Regulation (QMSR)?

54% of FDA Quality Management System Regulation (QMSR) you already have

NIST Cybersecurity Framework 2.0 already covers about 54% of FDA Quality Management System Regulation (QMSR), leaving 6 of 13 controls as genuinely new work.

Already covered 0 Likely covered 7 New work 6

No control in NIST Cybersecurity Framework 2.0 maps directly to one in FDA Quality Management System Regulation (QMSR). Everything counted as covered is covered because both map to the same third standard, which is what a crosswalk is, but it is an inference rather than a lookup.

What is genuinely new work

Nothing in NIST Cybersecurity Framework 2.0 reaches these. This is the list to scope.

QMSR-820.15

Clarification of concepts (§820.15)

QMSR-820.1_3_7

Scope, definitions and incorporation by reference (§§820.1, 820.3, 820.7)

QMSR-820.35

Control of records - record retention, audit trail, UDI, medical-device reporting (§820.35)

QMSR-Coord-ISO13485-MDR-IVDR-Part11

Coordination with ISO 13485:2016, EU MDR/IVDR, FDA Part 11, Cybersecurity Guidance

QMSR-Status

FDA QMSR - corpus status, enforcement landscape, future evolution

QMSR-Transition

Transition from prior QSR + 2 February 2026 application + FDA inspection approach

Show the 7 you already have

QMSR-820.10

Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)

QMSR-820.45

Device labelling and packaging controls (§820.45)

QMSR-ISO13485-Sec5

Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)

QMSR-ISO13485-Sec6

Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)

QMSR-ISO13485-Sec7_DesignControls

Product realization - Design and Development controls (ISO 13485:2016 Section 7.3)

QMSR-ISO13485-Sec7_Purchasing

Purchasing controls + supplier management (ISO 13485:2016 Section 7.4)

QMSR-ISO13485-Sec8

Measurement, analysis and improvement (ISO 13485:2016 Section 8)

How this is calculated

Already covered means a mapping runs from a control in NIST Cybersecurity Framework 2.0 to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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