Skip to content
MedTekOSTry the sandbox

Regulatory pathway · all topics

FDA Section 524B Cybersecurity Requirements

FD&C Act Section 524B (added by Consolidated Appropriations Act 2023) requires premarket submissions for cyber devices to include: a plan to monitor, identify, and address postmarket cybersecurity vulnerabilities and exploits; design, develop, and maintain processes that provide reasonable assurance the device and related systems are cybersecure; provide a software bill of materials (SBOM); and other information FDA may require. Applies to all submissions accepted after 1 October 2023. Implementation guidance is the Sept 2023 'Cybersecurity in Medical Devices' final guidance.

Source

FDA, 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions' (Sept 2023) and FD&C Act 524B

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions

How MedTek OS handles this

Compass drafts the fda section 524b cybersecurity requirements workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

Try the sandboxAsk the agent about this

Related pathways

IEC 81001-5-1 Health Software Security Lifecycle

IEC 81001-5-1:2021 specifies requirements for the activities throughout the health software lifecycle to address security. Covers planning, ...

510(k) Premarket Notification

A 510(k) clearance under 21 CFR Part 807 Subpart E demonstrates substantial equivalence to a legally marketed predicate device. Required for...

De Novo Classification Request

De Novo creates a new classification for a novel low-to-moderate risk device with no valid predicate. Submission under 21 CFR Part 860 Subpa...

Premarket Approval (PMA)

PMA is the most stringent FDA pathway, required for Class III devices that support or sustain human life or pose significant risk. Filed und...