--- title: "Premarket Cybersecurity Submission… | MedTech Terms" description: "The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/premarket-cybersecurity#term", "name": "Premarket Cybersecurity Submission", "alternateName": "Cybersecurity premarket package", "description": "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. 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Premarket Cybersecurity Submission [All terms](/terms) Cybersecurity [Regulated Pathways](/ecosystems/regulated-pathways)[Connected & Cyber-Physical Devices](/ecosystems/connected-devices) # 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. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A premarket cybersecurity submission is the formal collection of cybersecurity documentation - threat model, risk assessment, security architecture views, [SBOM](/terms/sbom), vulnerability management plan, security testing results, and end-user [labeling](/terms/labeling) - that FDA requires under section [524B](/terms/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 the regulation says FDA expects the submission to demonstrate a [Secure Product Development Framework](/terms/spdf) (SPDF) - meaning cybersecurity is engineered in, not bolted on. Reviewers look for: a comprehensive [STRIDE](/terms/stride) or similar threat model traceable to the device's [intended use](/terms/intended-use); a cybersecurity risk assessment integrated with [ISO 14971](/terms/iso-14971) safety risk; security architecture views (global system, multi-patient harm, updateability/ [patchability](/terms/patchability), security use case); a [CycloneDX](/terms/cyclonedx) or [SPDX](/terms/spdx) [SBOM](/terms/sbom) with vulnerability and end-of-support information; testing evidence (vulnerability scanning, [penetration testing](/terms/pen-test), fuzz testing, SAST/DAST); a [coordinated vulnerability disclosure](/terms/cvd) process; and [labeling](/terms/labeling) that informs operators about the device's security posture. ## 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](/terms/sbom) from CI/CD, [pen test](/terms/pen-test) before [V&V](/terms/verification-validation) freeze, [labeling](/terms/labeling) alongside the [IFU](/terms/ifu). Late-stage scrambling to assemble the package is the leading cause of Refuse-to-Accept findings and Major Deficiency letters. Common pitfalls - • 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 What's the difference between the 2014, 2018, and 2023 FDA cybersecurity guidances? The 2014 guidance (premarket) and 2016 guidance (postmarket) were short and high-level. The 2018 draft introduced Tier 1/Tier 2 device tiers. The September 2023 final guidance is the current authority - it consolidates premarket expectations and operationalizes the section [524B](/terms/section-524b) statutory requirements. Do I need penetration testing for a Class II 510(k)? What's an SPDF? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ Threat Modeling ](/terms/threat-modeling) - [ Secure Product Development Framework(SPDF) ](/terms/spdf) ### Used by Things that build on this term. - [ Section 524B of the FD&C Act(524B) ](/terms/section-524b) ### See also Closely related context worth reading. - [ Manufacturer Disclosure Statement for Medical Device Security(MDS2) ](/terms/mds2) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Cybersecurity Section 524B of the FD&C Act(524B) The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices. ](/terms/section-524b)[ Cybersecurity Secure Product Development Framework(SPDF) A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle. ](/terms/spdf)[ Cybersecurity Software Bill of Materials(SBOM) A machine-readable inventory of all software components, including open-source and third-party libraries, used to build a medical device. ](/terms/sbom)[ Cybersecurity Threat Modeling A structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat. ](/terms/threat-modeling) ### FDA Cybersecurity 101 · From this learning path [ Cybersecurity Common Vulnerabilities and Exposures(CVE) A globally unique identifier for a publicly disclosed cybersecurity vulnerability. ](/terms/cve?from=fda-cybersecurity-101)[ Cybersecurity Common Vulnerability Scoring System(CVSS) An industry-standard 0–10 score that quantifies the severity of a software vulnerability. ](/terms/cvss?from=fda-cybersecurity-101)[ Cybersecurity CycloneDX A lightweight, OWASP-maintained SBOM format designed for application security and supply-chain use cases. ](/terms/cyclonedx?from=fda-cybersecurity-101)[ Cybersecurity STRIDE Threat Model(STRIDE) A six-category framework for enumerating threats: Spoofing, Tampering, Repudiation, Information disclosure, Denial of service, Elevation of privilege. ](/terms/stride?from=fda-cybersecurity-101) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [FDA Cybersecurity 101](/paths/fda-cybersecurity-101)Lesson 2 of 11 Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 ISO/IEC· 1 1. [1 Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Sept 2023) Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions) 2. [2 FDA Digital Health Center of Excellence - Cybersecurity Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity) 3. [3 IEC 81001-5-1: Health software - Security activities in the product life cycle Verified ISO/IEC · iso.org ](https://www.iso.org/standard/76097.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building your premarket cybersecurity package? We help MedTech manufacturers assemble the threat model, SBOM, and risk assessment artifacts FDA reviewers look for. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Cybersecurity Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=premarket-cybersecurity) Learn in 60 seconds Card Lesson Quiz The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device. - · 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. Remember this Watch out: Building the cybersecurity package after V&V is frozen - gaps surface that require design changes. Related terms - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [Software Bill of Materials(SBOM) ](/terms/sbom) - [Secure Product Development Framework(SPDF) ](/terms/spdf) - [Threat Modeling ](/terms/threat-modeling) - [Penetration Testing ](/terms/pen-test) - [IEC 81001-5-1 ](/terms/iec-81001-5-1) You may also need Auto-suggested from Cybersecurity and shared keywords. - [Refuse to Accept (Cybersecurity)(RTA (cyber)) ](/terms/rta-cyber) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [FedRAMP(FedRAMP) ](/terms/fedramp) - [AAMI SW96 ](/terms/aami-sw96) - [AAMI TIR57 ](/terms/aami-tir57) - [CISA Known Exploited Vulnerabilities Catalog(KEV) ](/terms/kev) [All Cybersecurity terms](/terms?cat=Cybersecurity) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Cyber Tips Practical, organized tips for medical device cybersecurity teams. ](https://medtechcybertips.com) - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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