FDA Cybersecurity vs ISO 14971
What's actually different between the QMS regulations medical device manufacturers must follow — clause-by-clause comparison from the Kelsey Quality crosswalk library.
kelseyqms.com/crosswalk/compare/cybersecurity-vs-iso-14971
COMPARE
vs
13FDA CYBER REQUIREMENTS
3SHARED IN BOTH
10NEW IN FDA CYBER
9RETIRED FROM ISO 14971
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONFDA CYBERSECURITYISO 14971
OVERVIEW
StatusCurrent — guidance document, not regulationCurrent — recognized consensus standard
Effective periodSep 2023 – present2019 – present
Total requirements139
SCOPE
Risk integrationCybersecurity risks must integrate with the ISO 14971 risk management fileDefines the risk management framework; all other standards reference it
Plan maintenancePatch management plan updated when new threats or vulnerabilities identifiedRisk management plan required before analysis begins; updated through lifecycle
Document approvalAccepted residual risks require signed statements from an authorized individualRisk management activities assigned to named roles; records in risk file
OPERATIONAL
Most common gapIncomplete threat models lacking system context, interfaces, or environment diagramsRisk management file created after design, not integrated from the beginning
Audit focusPremarket submission completeness; threat model depth; FDA deficiency lettersRisk file traceability: Plan, FMEA, and Report linked as a coherent record
COVERAGE BREAKDOWN
What's shared, what's distinct
3SHARED IN BOTH
- • Threat Model Documentation
- • Cybersecurity Risk Assessment
- • SOUP Risk Assessment
10ONLY IN FDA CYBER
- • Software Bill of Materials
- • Vulnerability Assessment and Management
- • Patch and Update Management Plan
- • Coordinated Vulnerability Disclosure
- • End-of-Life Cybersecurity Plan
- • Penetration Testing Evidence
- + 4 more
9ONLY IN ISO 14971
- • Risk Management Process
- • Risk Management Plan
- • Intended Use and Reasonably Foreseeable Misuse
- • Hazard Identification and Risk Estimation
- • Risk Evaluation Against Acceptability Criteria
- • Risk Control Option Analysis
- + 3 more
OTHER COMPARISONS