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Premarket vs. postmarket cybersecurity duties - Infographic

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FDA Regulation

Premarket vs. postmarket cybersecurity duties

What the FDA expects before clearance and what continues after, side by side.

Two-column infographic. Premarket, under the February 2026 guidance and Section 524B: threat model, architecture views, SBOM, testing, unresolved anomalies, labeling, postmarket plan. Postmarket, under the December 2016 guidance and Section 524B: monitoring, coordinated disclosure, controlled vs. uncontrolled risk, patching, out-of-cycle fixes, ISAO sharing, and FDA reporting when required. — The December 2016 postmarket guidance is still the FDA's current dedicated postmarket guidance.

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What the graphic says

The full text version, so the content is readable without the image.

Before clearance (premarket)

February 2026 premarket guidance and Section 524B.

Threat model and risk assessment: Security risk assessment tied to the threat model.
Architecture views: Security architecture views of the system.
SBOM: With support status for each component.
Testing: Penetration and security testing.
Unresolved anomalies: Assessed for security impact.
Labeling: Security information for users and hospitals.
Postmarket plan: How the device will be kept secure after clearance.

After clearance (postmarket)

December 2016 postmarket guidance and Section 524B.

Monitoring: Watch for new vulnerabilities.
Coordinated disclosure: Accept and act on outside vulnerability reports.
Risk assessment: Decide whether risk is controlled or uncontrolled.
Patching: Updates on a set cycle, critical fixes out of cycle.
Information sharing: Share through an ISAO.
Reporting: Report to the FDA when required.

Keep reading

FDA cybersecurity guidance overview
Postmarket monitoring program
FDA cybersecurity guidance timeline

More in FDA Regulation

Infographic timeline: October 2014 first premarket guidance; December 28, 2016 postmarket guidance; December 29, 2022 Section 524B enacted; March 29, 2023 Section 524B in effect; September 27, 2023 premarket guidance; October 1, 2023 refuse-to-accept begins; June 27, 2025 updated premarket guidance; February 3, 2026 current premarket guidance.

FDA medical device cybersecurity timeline, 2014 to 2026

Infographic listing ten eSTAR cybersecurity documents: threat model, security risk assessment, security architecture views, SBOM, unresolved anomalies, cybersecurity testing, traceability, cybersecurity management plan, labeling, and risk management report.

What goes in the eSTAR cybersecurity section

Infographic with four cards: postmarket vulnerability plan with coordinated disclosure, secure design processes with updates and patches, SBOM, and other requirements the FDA sets by regulation, each paired with its evidence.

Section 524B checklist for cyber devices

Refuse to accept vs. hold letter vs. deficiency letter

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Full-Service FDA Premarket Cybersecurity
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FDA Postmarket Cybersecurity
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MedTech Cybersecurity · Since 2022