--- title: "Cybersecurity of Medical Devices: FDA's Final Premarket Guidance" description: Register now and view the on-demand version of our webinar to gain a clear and practical overview of the FDA’s final premarket cybersecurity guidance. --- [![Logo PQE Group - azzurro - 2024](https://webinar.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) ## On Demand Webinar # Cybersecurity of Medical Devices: FDA's Final Premarket Guidance ## What Manufacturers Need to Know ## Abstract On February 2, 2026, the FDA's Quality Management System Regulation (QMSR) took effect, replacing 21 CFR Part 820 and incorporating ISO 13485:2016 by reference. One day later, FDA reissued its premarket cybersecurity guidance to align with it. FDA classifies the guidance itself as Level 2 — a technical alignment rather than a substantive policy change — but the inspection context is new: under Compliance Program 7382.850, which replaces the legacy QSIT model, security findings now surface within design controls, CAPA, and risk management reviews as routine inspection items. For cyber device manufacturers, cybersecurity is no longer a standalone compliance exercise — it is now an integral part of the quality management system. Incomplete cybersecurity content can trigger FDA's Refuse-to-Accept authority at submission and generate inspection findings against the QMS itself. In this webinar, two industry experts will break down what these regulatory changes mean in practice — and what you need to do now to stay compliant. ## You will learn - ![check mark](https://webinar.pqegroup.com/hubfs/white-check.svg)Which products fall within FDA's "cyber device" definition under §524B(c) — including edge cases that catch manufacturers off guard (dormant wireless, service-only interfaces, future-connectivity-capable designs) - ![check mark](https://webinar.pqegroup.com/hubfs/white-check.svg)The four §524B(b) statutory requirements — postmarket cybersecurity plan, reasonable assurance that the device and related systems are cybersecure, update/patch availability, and a -Software Bill of Materials (with FDA's guidance expectation that the SBOM be machine-readable) - ![check mark](https://webinar.pqegroup.com/hubfs/white-check.svg)The premarket documentation FDA expects — threat modeling, security risk assessment, architecture views (global system, multi-patient harm, updatability/patchability), interface analysis, and security testing evidence - ![check mark](https://webinar.pqegroup.com/hubfs/white-check.svg)How to integrate a Secure Product Development Framework (SPDF) into your QMS using FDA-recognized standards for secure product development (IEC 81001-5-1 and ANSI/AAMI SW96:2023) - ![check mark](https://webinar.pqegroup.com/hubfs/white-check.svg)Common pitfalls that lead to Refuse-to-Accept decisions or inspection findings — and how to avoid them ## **Speakers** ![Danilo-May-13-2026-09-09-25-3409-AM](https://webinar.pqegroup.com/hs-fs/hubfs/Danilo-May-13-2026-09-09-25-3409-AM.png?width=200&height=200&name=Danilo-May-13-2026-09-09-25-3409-AM.png "Danilo-May-13-2026-09-09-25-3409-AM") ## **Danilo Maruccia** Speaker Principal Consultant PQE Group ![Eugneio](https://webinar.pqegroup.com/hs-fs/hubfs/Eugneio.png?width=200&height=200&name=Eugneio.png "Eugneio") ## **Eugenio Saccon** Speaker Lead Penetration Tester PQE Group ![Natalia](https://webinar.pqegroup.com/hs-fs/hubfs/Natalia.png?width=200&height=200&name=Natalia.png "Natalia") ## **Natalia Grzelak-Zok  ** Moderator Medical Device Product Security Management Consultant PQE Group ![new PQE logo white tagline](https://webinar.pqegroup.com/hubfs/new%20PQE%20logo%20white%20tagline.png) ISO 9001 Certified compliance services provider since 1998.   ![Logo ISO 9001](https://webinar.pqegroup.com/hs-fs/hubfs/Logo%20ISO%209001.png?width=125&name=Logo%20ISO%209001.png)   - Discover PQE - [Work with PQE](https://www2.pqegroup.com/careers/) - [Locations](https://www2.pqegroup.com/contact-us/#locations) - [About](https://www2.pqegroup.com/about/) - [Blog](https://blog.pqegroup.com/) - Useful Links - [Privacy Notice](https://www2.pqegroup.com/privacy-notice/) - [Cookie Policy](https://www2.pqegroup.com/cookie-policy/) - [Model of Organization](https://www2.pqegroup.com/model-of-organization/) - [Ethical Code](https://www2.pqegroup.com/ethical-code/) English CHANGE LANGUAGE Copyright **2024** | Proudly powered by **PQE Group Creative Team** [LinkedIn](https://www.linkedin.com/company/pqe-group) [![twitter](https://webinar.pqegroup.com/hubfs/twitter-w.png) Twitter](https://twitter.com/PQEGroup) [Facebook](https://www.facebook.com/PQEGroup/) [Instagram](https://www.instagram.com/lifeatpqe) [YouTube](https://www.youtube.com/c/PQEGroup) [Xing](https://www.xing.com/pages/pqegroup)