FDA Premarket Cybersecurity

The FDA's February 2026 final guidance and Section 524B of the FD&C Act reshaped what reviewers expect in a 510(k), De Novo, or PMA cybersecurity package. This hub pulls together our services, in-depth guides, standards reference, and answers to the questions teams ask us most often.

Services

• Full-Service FDA Premarket Cybersecurity

  Full-service, end-to-end: we deliver 100% of the artifacts FDA reviewers expect for 510(k), De Novo, and PMA submissions - traceable, complete, and aligned with current 524B guidance.

• FDA Deficiency Response

  Rapid-response team that resolves FDA cybersecurity deficiencies on the first resubmission - across 510(k), De Novo, PMA, and HDE.

• Medical Device Threat Modeling

  Comprehensive threat modeling per FDA Section V.A.1 - covering supply chain, deployment, environment of use, and decommission risks for the full device system.

• Secure MedTech Product Design

  Architecture review, control selection, and secure development guidance from concept through V&V - aligned with FDA's Secure Product Development Framework.

In-depth guides

• 12 Reasons the FDA Rejects Cybersecurity SubmissionsFree Submission Guide · Feb 2026 FDA Guidance · Section 524B 12 Reasons the FDA Rejects Medical Device Cybersecurity Submissions A practical, ungated guide to the most common cybersecurity deficiencies in 510(k), De Novo, and PMA submissions - what triggers each one, and exactly how to fix it before
• FDA Cybersecurity Deficiency Response Checklist⚡ Free Resource · Updated 2026 FDA Cybersecurity Deficiency LetterResponse Checklist A step-by-step, 11-stage checklist for organizing and resolving your FDA cybersecurity deficiency for 510(k), PMA, De Novo, and HDE submissions. Aligned with the FDA’s February 2026 final guidance and Section 524B o
• The SPDF PlaybookSPDF PLAYBOOK · FDA CYBERSECURITY GUIDE The SPDF Playbook for FDA-Ready Medical Devices A practical, ungated guide to building a Secure Product Development Framework that FDA accepts. The eight pillars, the artifacts each one produces, and a pre-submission readiness checklist you can score yourself
• The MedTech Cybersecurity Standards DecoderA plain-English field guide to FDA Section 524B, IEC 81001-5-1, AAMI TIR57, ANSI/AAMI SW96, ISO 14971, and 8 more medical device cybersecurity standards. What they require, how they connect, and what the FDA expects to see in your eSTAR premarket submission.

Standards & guidance

Defined entries from our MedTech Cybersecurity Standards Glossary.

• FDA 2026 GuidanceFDA Premarket Cybersecurity Guidance (Feb 3, 2026)The FDA's final premarket cybersecurity guidance, effective February 3, 2026. Defines the seven-section cybersecurity submission format reviewers now enforce at Technical Screening, replacing the 2023 draft. Operationalizes Section 524B of the FD&C Act.
• Section 524BFD&C Act Cyber Device RequirementsAdded by the Consolidated Appropriations Act, 2023, Section 524B gives the FDA explicit authority to require a complete cybersecurity package in every premarket submission for a cyber device, and to refuse submissions that lack one.
• eSTARElectronic Submission TemplateFDA's mandatory interactive submission template with structured upload slots for each cybersecurity artifact.
• SPDFSecure Product Development FrameworkA documented framework that shows security activities are integrated across the device lifecycle - not bolted on at the end. Includes secure requirements, threat modeling, secure coding, V&V, vulnerability management, and post-market response.
• ISO 13485Medical Device Quality Management SystemThe international QMS standard for MedTech. Covers design controls, document control, CAPA, supplier management, and post-market surveillance. The QMSR final rule (effective Feb 2, 2026) harmonizes 21 CFR Part 820 with ISO 13485.

From the blog

• 510(k) Cybersecurity Requirements Every Maker Must MeetMost 510(k) deficiencies don't fail on clinical data. They fail on cybersecurity. FDA reviewers are sending Additional Information (AI) requests, and outright Refuse-to-Accept (RTA) holds, at a rate that has become the primary timeline risk for connected device submissions. The documentation bar has
• A Guide to FDA Cybersecurity DocumentationFDA cybersecurity documentation requirements (2025): 524B cyber device rules, SPDF, SBOM, threat modeling, testing, and a premarket submission checklist.
• 21 CFR Part 820 and Medical Device CybersecurityUpdated October 26, 2024 The development, manufacturing, and management of medical devices require strict regulatory adherence to ensure these products' safety, effectiveness, and reliability. A key regulatory framework governing this process is 21 CFR Part 820, often called the Quality System Regul
• A New Era for Quality and Safety: What the FDA’s QMSR Means for CybersecurityFDA’s QMSR is now in effect. See why connected MedTech teams must build cybersecurity into the QMS - risk management, V&V, suppliers, and postmarket.

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