Premarket Cybersecurity Submission
The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.
Definition
A premarket cybersecurity submission is the formal collection of cybersecurity documentation - threat model, risk assessment, security architecture views, SBOM, vulnerability management plan, security testing results, and end-user labeling - that FDA requires under section 524B for any cyber device. The September 2023 FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" describes the expected content in detail, replacing the 2014 and 2018 draft guidances.What this means in practice
The premarket package is the single largest cybersecurity deliverable a MedTech team produces. Most successful teams build it incrementally throughout development rather than at the end - threat model in design phase, SBOM from CI/CD, pen test before V&V freeze, labeling alongside the IFU. Late-stage scrambling to assemble the package is the leading cause of Refuse-to-Accept findings and Major Deficiency letters.Examples
- A manufacturer developing a new infusion pump ensures its premarket cybersecurity submission includes a detailed threat model identifying potential risks like unauthorized access and data tampering.
- For a novel diagnostic imaging system, the MedTech team generates a comprehensive Software Bill of Materials (SBOM) to be part of the premarket package, documenting all third-party components.
- Before submitting a connected insulin delivery device, the sponsor conducts thorough penetration testing and includes the results and a vulnerability management plan in their premarket cybersecurity submission.
- •Building the cybersecurity package after V&V is frozen - gaps surface that require design changes.
- •Submitting a threat model that lists only generic threats (e.g., 'malware') without device-specific attack paths.
- •Treating penetration testing as a one-shot at submission instead of a recurring activity tied to design changes.
- •Failing to integrate cybersecurity risk into the ISO 14971 risk management file - FDA expects one unified risk picture.
Frequently asked questions
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsThe federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.
A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle.
A machine-readable inventory of all software components, including open-source and third-party libraries, used to build a medical device.
A structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat.
FDA Cybersecurity 101
· From this learning pathA globally unique identifier for a publicly disclosed cybersecurity vulnerability.
An industry-standard 0–10 score that quantifies the severity of a software vulnerability.
A lightweight, OWASP-maintained SBOM format designed for application security and supply-chain use cases.
A six-category framework for enumerating threats: Spoofing, Tampering, Repudiation, Information disclosure, Denial of service, Elevation of privilege.
Where this term appears across MedTech Terms.
- FDA Cybersecurity 101Lesson 2 of 11
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Sept 2023)Tier 2 VerifiedFDAfda.gov
- 2FDA Digital Health Center of Excellence - CybersecurityTier 2 VerifiedFDAfda.gov
- 3IEC 81001-5-1: Health software - Security activities in the product life cycleTier 1 VerifiedISO/IECiso.org
Inline markers like [1] jump to the matching reference above.